QWD

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Stimulator, Nerve, For Restless Legs Syndrome

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5887

Medical specialty

Neurology

FDA 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.

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