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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 a medical device manufactured by Helius Medical, Inc.. It received FDA 510(k) clearance on 2026-05-13 under approval 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. It is manufactured by Helius Medical, Inc.. The 510(k) number is K253061.

When was Portable Neuromodulation Stimulator (PoNS) approved by the FDA?

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

What company makes Portable Neuromodulation Stimulator (PoNS)?

Portable Neuromodulation Stimulator (PoNS) is manufactured by Helius Medical, Inc..

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

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

Official Source

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

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