FDA 510(k)

High Tone Power therapy (HiToP) (Model: HiToP PNP)

Número K: K252816 · 2026-06-02

Data da decisão2026-06-02

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Tone Power therapy (HiToP) (Model: HiToP PNP) is the device name listed in this FDA 510(k) record. The listed applicant is Mohammadali Nezakati. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K252816. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High Tone Power therapy (HiToP) (Model: HiToP PNP)?

High Tone Power therapy (HiToP) (Model: HiToP PNP) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Mohammadali Nezakati. The 510(k) number is K252816.

When did High Tone Power therapy (HiToP) (Model: HiToP PNP) receive FDA 510(k) clearance?

High Tone Power therapy (HiToP) (Model: HiToP PNP) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K252816.

Who is the listed applicant for High Tone Power therapy (HiToP) (Model: HiToP PNP)?

The FDA 510(k) record lists Mohammadali Nezakati as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Tone Power therapy (HiToP) (Model: HiToP PNP)?

The FDA product code for High Tone Power therapy (HiToP) (Model: HiToP PNP) is IPF.

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