FDA product code QWD

Stimulator, Nerve, For Restless Legs Syndrome

Neurology·Class 2·21 CFR 882.5887
US regulatory classifications
US Product Code (FDA)
QWD
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5887
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Stimulator, Nerve, For Restless Legs Syndrome is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.