Stimulator, Nerve, For Restless Legs Syndrome
The nerve stimulator for Restless Legs Syndrome (product code QWD) is a prescription external device that uses electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity, such as the peroneal nerves, to evoke sustained muscle activation and reduce symptoms of Restless Legs Syndrome. Classified as Class 2 in the Neurology specialty (regulation 882.5887), it requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWD
- Device Class
- FDA class 2
- Regulation Number
- 882.5887
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220059 | NTX100 Tonic Motor Activation (NTX100 ToMAc) System | Apr 17, 2023 | Unknown | Noctrix Health, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.