K253061
- 510(k) number
- K253061
- Device name
- Portable Neuromodulation Stimulator (PoNS)
- Applicant
- Helius Medical, Inc. PA · US
- Product code
- QCF — Electrical Tongue Stimulator To Treat Motor Deficits
- Decision date
- 2026-05-13
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253061.pdf
Official FDA record: K253061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.