FDA Product Code
FDA Product Code QCF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5889
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253061 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | 2026-05-13 | Traditional | PDF ↗ |
| DEN200050 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | 2021-03-26 | Direct | — |
Product code QCF · Class II · Neurology. Data: openFDA.