PKR

Non-Invasive Vagus Nerve Stimulator - Headache

Product code

PKR

Device name

Non-Invasive Vagus Nerve Stimulator - Headache

Device class

Class 2

21 CFR

21 CFR 882.5892

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).