The following data is part of a De Novo classification by Helius Medical, Inc. with the FDA for Portable Neuromodulation Stimulator (pons).
| DeNovo ID | DEN200050 |
| Device Name: | Portable Neuromodulation Stimulator (PoNS) |
| Classification | Neuromuscular Tongue Stimulator To Treat Motor Deficits |
| Applicant | Helius Medical, Inc. 642 Newtown Yardley Road, Suite 100 Newtown, PA 18940 |
| Contact | Lawrence Picciano |
| Product Code | QCF |
| CFR Regulation Number | 882.5889 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2020-08-04 |
| Decision Date | 2021-03-26 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864288000431 | DEN200050 | 000 |
| 00864288000462 | DEN200050 | 000 |
| 00864288000448 | DEN200050 | 000 |