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FDA 510(k)

Portable Neuromodulation Stimulator (PoNS)

K-Number: K253061 · 2026-05-13

ApplicantHelius Medical, Inc.
Decision Date2026-05-13
Product CodeQCF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Portable Neuromodulation Stimulator (PoNS) is the device name listed in this FDA 510(k) record. The listed applicant is Helius Medical, Inc.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K253061. The device is classified under product code QCF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Neuromodulation Stimulator (PoNS)?

Portable Neuromodulation Stimulator (PoNS) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Helius Medical, Inc.. The 510(k) number is K253061.

When did Portable Neuromodulation Stimulator (PoNS) receive FDA 510(k) clearance?

Portable Neuromodulation Stimulator (PoNS) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K253061.

Who is the listed applicant for Portable Neuromodulation Stimulator (PoNS)?

The FDA 510(k) record lists Helius Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Neuromodulation Stimulator (PoNS)?

The FDA product code for Portable Neuromodulation Stimulator (PoNS) is QCF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05135533Neuromodulation and Dynamic Balance in StrokeCOMPLETEDNCT07656129Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's DiseaseNOT_YET_RECRUITING

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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