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.

Clearance details

Applicant: Helius Medical, Inc.
Product code: 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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