Nerivio; Nerivio Infinity

Nerivio and Nerivio Infinity are wearable, battery-powered Remote Electrical Neuromodulation (REN) devices for acute and preventive treatment of migraine with or without aura in patients 8 years and older. The devices deliver low-energy electrical pulses to the upper arm for 45 minutes per treatment via electrodes, controlled through a mobile app for home self-administration at migraine onset or every other day for prevention.

Both devices use biphasic rectangular modulated waveforms with 40 mA maximum output current at 500Ω impedance, 110 Hz average frequency, and 25 cm² electrode area. Nerivio has a non-rechargeable battery and non-replaceable electrodes; Nerivio Infinity has a rechargeable battery and disposable replaceable electrode pads. The subject Nerivio Infinity adds NFC tag authentication for electrodes, updated mobile app software for newer operating systems and bug fixes, and an alternate armband coating for supply chain flexibility.

Not stated in this summary.

The subject devices maintain identical indications for use, core electrical output parameters (40 mA max, 110 Hz, biphasic waveform), treatment duration (45 minutes), and therapeutic principle (REN for migraine) as the predicate K241756. The minor technological additions—NFC authentication, app updates, and armband coating—do not alter the fundamental electrical stimulus delivery mechanism or clinical purpose. Clinical data from post-market studies on long-term safety and pregnancy use were incorporated into labeling precautions but do not change the device's therapeutic function. Therefore, the devices are substantially equivalent because they pose no new questions of safety or effectiveness.