DEN210046 is an FDA 510(k) submission for the Quell-FM. This device is classified as a Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms (Class II - Special Controls, product code QSQ).
Submitted by Neurometrix, Inc. (Woburn, US). The FDA issued a Not Cleared (DENG) decision on May 18, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5888. Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms..
| 510(k) Number | DEN210046 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 05, 2021 |
| Decision Date | May 18, 2022 |
| Days to Decision | 225 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QSQ - Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5888 |
| Definition | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms. |