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FDA 510(k)

Portable Neuromodulation Stimulator (PoNS)

Número K: K253061 · 2026-05-13

RequerenteHelius Medical, Inc.
Data da decisão2026-05-13
Código do produtoQCF
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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