QCF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5889
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Portable Neuromodulation Stimulator (PoNS) (K253061) | Helius Medical, Inc. | 2026-05-13 |
| Portable Neuromodulation Stimulator (PoNS) (DEN200050) | Helius Medical, Inc. | 2021-03-26 |
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