QWD · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5887
Classification
FDA Product Code
QWD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5887
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.