OTODYNAMICS LIMITED ON2-CASE-KIT OtoNova Pro Case Service Kit

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

OtoNova Pro OAE & ABR device for wireless use with tablet, smartphone, or PC (instrument only - no system items)

Case (enclosure) service kit for Otoport/Otocheck

Case 4X1 VITA Shades

LUMINARY LED CURING LIGHT

The CLEARinse Pro is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of saline into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can be used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement maneuver. The device consists of a hand held battery operated unit with a disposable tip portion. A charger is provided with the device.

Cap for hair growth, photobiomodulation. 272 laser diode device with 6 minute treatment time.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

OtoNova Pro OAE & ABR device for wireless use with tablet, smartphone, or PC (instrument only - no system items)

Case (enclosure) service kit for Otoport/Otocheck