QWDClass II
Stimulator, Nerve, For Restless Legs Syndrome
21 CFR 882.5887 / Neurology
QWD is the FDA product code for Stimulator, Nerve, For Restless Legs Syndrome, a class II device type, regulated under 21 CFR 882.5887. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QWD
- Device name
- Stimulator, Nerve, For Restless Legs Syndrome
- 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.
- Regulation
- 21 CFR 882.5887
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QWD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QWD| Applicant | Clearances |
|---|---|
| Noctrix Health, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.