QWD

Stimulator, Nerve, For Restless Legs Syndrome

Product code

QWD

Device name

Stimulator, Nerve, For Restless Legs Syndrome

Device class

Class 2

21 CFR

21 CFR 882.5887

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.

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