QWD — Stimulator, Nerve, For Restless Legs Syndrome Class II
FDA product code QWD covers "Stimulator, Nerve, For Restless Legs Syndrome", a Class II medical device regulated under 21 CFR 882.5887. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWD
- Device Class
- Class II
- Regulation Number
- 882.5887
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220059 | noctrix health | NTX100 Tonic Motor Activation (NTX100 ToMAc) System | April 17, 2023 |