# Helius Medical, Inc.

- Location (FDA's records): Newton, PA
- FDA decisions: 2 (2021–2026): 1 510(k) clearance and 1 De Novo grant
- Product codes: QCF (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN200050: Portable Neuromodulation Stimulator (PoNS) (2021), cited by 1

## Recent decisions
- K253061: Portable Neuromodulation Stimulator (PoNS) (May 13, 2026)
- DEN200050: Portable Neuromodulation Stimulator (PoNS) (Mar 26, 2021)

Source page: https://510kreport.com/company/helius-medical