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U.S. Department of Health and Human Services

Product Classification

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Device non-invasive vagus nerve stimulator - headache
Regulation Description External vagal nerve stimulator for headache.
Definition The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Physical State The device is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a control to power on the device and control stimulation intensity, and a pair of stainless steel skin contact surfaces.
Technical Method The device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve. The strength of the stimulation is lower than that required to activate efferent vagus nerve stimulation that mediates cardiac specific effects. Conductive electrode gel is provided for use with the device.
Target Area The device is used on the side of the neck for non-invasive Vagus Nerve Stimulation (nVNS).
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePKR
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5892
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible