510(k) DEN200050 ยท QCF Electrical Tongue Stimulator To Treat Motor Deficits
Portable Neuromodulation Stimulator (PoNS)
| Applicant | Helius Medical, Inc., Newton PA, US |
| Decision | Unknown, Mar 26, 2021 |
| Received | Aug 4, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200050
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.