Product code QWD

Device name

Stimulator, Nerve, For Restless Legs Syndrome

Medical specialty

Neurology

Device class

2

Regulation number

882.5887

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset