Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
The Transcutaneous Electrical Nerve Stimulator to Treat Fibromyalgia Symptoms is a device that delivers controlled electrical stimulation through the skin to peripheral nerves for the purpose of reducing pain and other symptoms associated with fibromyalgia. It provides a non-pharmacological therapeutic option for this chronic widespread pain condition. Classified as FDA Class 2 under regulation 882.5888, it requires 510(k) clearance in the Neurology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSQ
- Device Class
- FDA class 2
- Regulation Number
- 882.5888
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
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 |
|---|---|---|---|---|
| DEN210046 | Quell-FM | May 18, 2022 | Unknown | Neurometrix, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.