gammaCore-S 300 is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (to indicate device status), and a pair of stainless steel skin contact or stimulation surfaces. gammaCore-S 300 uses two buttons to power on the device and for operator control of the signal amplitude / stimulation intensity. The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S 300 device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 300 2-minute treatments) over a 31-day period that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more.

gammaCore Sapphire, part number 10016-40301, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It is programmed to deliver up to 30 doses per day for 10 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire, part number 10016-40302, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver up to 30 doses per day for 31 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire, part number 10016-40303, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver up to 30 doses per day for 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.

Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.

Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.

gammaCore-S 250 is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (to indicate device status), and a pair of stainless-steel skin contact or stimulation surfaces. gammaCore-S 250 uses two buttons to power on the device and for operator control of the signal amplitude / stimulation intensity. The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S 250 device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 250 2-minute treatments) over its service life (gammaCore-S 250 service life is defined as 250 treatments or when the on-board batteries are fully discharged) that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more.

gammaCore Sapphire 3 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It is programmed to deliver 24 doses per day for 93 days. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40302 is programmed to deliver 24 doses per day for 6 months. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40304 is programmed to deliver 24 doses per day for 24 months (2 years). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40305 is programmed to deliver 24 doses per day for 36 months (3 years). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 93-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 31-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire SLC 93-Day DEMO Refill Card Kit intended to be used to refill / reload the DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 62-Day DEMO Refill Card Kit intended to be used to refill / reload the DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire SLC 93-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 12-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 24-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 36-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 62-Day DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 93-Day DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 12-Month DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 36-Month DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 31-Day Refill Card Kit intended for use with gammaCore Sapphire Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire 93-Day Refill Card Kit intended for use with gammaCore Sapphire Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire 6-Month Refill Card Kit intended for use with gammaCore Sapphire Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire 12-Month Refill Card Kit intended for use with gammaCore Sapphire Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire 62-Day DEMO Refill Card Kit intended to be used to refill / reload the DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 93-Day DEMO Refill Card Kit intended to be used to refill / reload the DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire 12-Month DEMO Refill Card Kit intended to be used to refill / reload the DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 12-Month Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 93-Day DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 12-Month DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 31-Day Refill Card Kit intended for use with gammaCore Sapphire R Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire R 93-Day Refill Card Kit intended for use with gammaCore Sapphire R Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire R 12-Month Refill Card Kit intended for use with gammaCore Sapphire R Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

gammaCore Sapphire R 93-Day DEMO Refill Card Kit intended to be used to refill / reload the gammaCore Sapphire R DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

gammaCore Sapphire R 12-Month DEMO Refill Card Kit intended to be used to refill / reload the gammaCore Sapphire R DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.