| Device |
non-invasive vagus nerve stimulator for migraine 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 migraine headache. |
| 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 Code | QAK |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine 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
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
