FDA product code QWD: Stimulator, Nerve, For Restless Legs Syndrome
QWD is the FDA product code for stimulator, nerve, for restless legs syndrome. It is a Class II device, regulated under 21 CFR 882.5887 and reviewed by the Neurology panel. Devices under QWD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, For Restless Legs Syndrome |
| Device class | Class II |
| Regulation | 21 CFR 882.5887 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QWD devices
openFDA lists no recalls for product code QWD.
Frequently asked questions
What is FDA product code QWD?
QWD is the FDA product code for stimulator, nerve, for restless legs syndrome. It is a Class II device, regulated under 21 CFR 882.5887 and reviewed by the Neurology panel.
What device class is QWD?
Class II, regulation 21 CFR 882.5887. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QWD
- Run a recall and safety report across every QWD manufacturer
- Watch product code QWD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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