Theranica Bio-Electronics Ltd. FGD000100 NerivioInfinity

NerivioInfinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]).NerivioInfinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The electrodes are disposable and replaceable. A single electrode kit is sufficient for up to 18 treatments of 45 minutes each.The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.The NerivioInfinity package under this UDI contains 1 electrode.