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

Name: FDA 510(k) clearance K253061
Creator: U.S. Food and Drug Administration
Published: 2026-05-13

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.. Device class: 2.

Summary

Helius Medical's Portable Neuromodulation Stimulator (PoNS) is filed under QCF, which the record names "Electrical Tongue Stimulator To Treat Motor Deficits".

Class II, 21 CFR 882.5889. Neurology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Helius filed from Newton, Pennsylvania. Review took 233 calendar days (September 22, 2025 to May 13, 2026).

Clearance details

Applicant: Helius Medical, Inc.
Product code: Product code QCF
Device class: Class 2
Regulation: 21 CFR 882.5889
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 ↗

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