FDA 510(k)

Electrically Powered Wheelchair -Model HP358E

Número K: K201855 · 2021-09-28

RequerenteKunshan Hi-Fortune Health Products Co., Ltd.

Data da decisão2021-09-28

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electrically Powered Wheelchair -Model HP358E is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K201855. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Electrically Powered Wheelchair -Model HP358E?

Electrically Powered Wheelchair -Model HP358E is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K201855.

When did Electrically Powered Wheelchair -Model HP358E receive FDA 510(k) clearance?

Electrically Powered Wheelchair -Model HP358E received FDA 510(k) clearance on 2021-09-28, under 510(k) number K201855.

Who is the listed applicant for Electrically Powered Wheelchair -Model HP358E?

The FDA 510(k) record lists Kunshan Hi-Fortune Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrically Powered Wheelchair -Model HP358E?

The FDA product code for Electrically Powered Wheelchair -Model HP358E is ITI.

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Outros registros que listam Kunshan Hi-Fortune Health Products Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: ITI)

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Fonte oficial

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