Portable Neuromodulation Stimulator (PoNS)— 510(k) K253061

Substantially Equivalent

Helius Medical, Inc.

FDA 510(k) clearance K253061 for Portable Neuromodulation Stimulator (PoNS), Substantially Equivalent on 2026-05-13. Applicant: Helius Medical, Inc..

Clearance details

Applicant: Helius Medical, Inc.
Product code: Code QCF
Advisory panel: Neurology
Date received: 2025-09-22
Decision date: 2026-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.