DEN200050 is an FDA 510(k) submission for the Portable Neuromodulation Stimulator (PoNS). This device is classified as a Electrical Tongue Stimulator To Treat Motor Deficits (Class II - Special Controls, product code QCF).
Submitted by Helius Medical, Inc. (Newton, US). The FDA issued a Not Cleared (DENG) decision on March 26, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5889. An Electrical Tongue Nerve Stimulator To Treat Motor Deficits Is A Prescription Device That Consists Of A Non-implantable Apparatus To Generate Electrical Pulses For Stimulation Of The Nerves In The Tongue To Provide Treatment Of Motor Deficits..
| 510(k) Number | DEN200050 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 04, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 234 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QCF - Electrical Tongue Stimulator To Treat Motor Deficits |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5889 |
| Definition | An Electrical Tongue Nerve Stimulator To Treat Motor Deficits Is A Prescription Device That Consists Of A Non-implantable Apparatus To Generate Electrical Pulses For Stimulation Of The Nerves In The Tongue To Provide Treatment Of Motor Deficits. |