FDA 510(k)

HP458E Electrically Powered Wheelchair

Número K: K212503 · 2022-01-18

RequerenteKunshan Hi-Fortune Health Products Co., Ltd.

Data da decisão2022-01-18

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

HP458E Electrically Powered Wheelchair 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 2022-01-18 under 510(k) number K212503. 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 HP458E Electrically Powered Wheelchair?

HP458E Electrically Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K212503.

When did HP458E Electrically Powered Wheelchair receive FDA 510(k) clearance?

HP458E Electrically Powered Wheelchair received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212503.

Who is the listed applicant for HP458E Electrically Powered Wheelchair?

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 HP458E Electrically Powered Wheelchair?

The FDA product code for HP458E Electrically Powered Wheelchair is ITI.

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

K244003Electrically powered wheelchair K243962Electrically Powered Wheelchair K243961Electrically Powered Wheelchair K241337Electrically powered wheelchair (HP202)K241632Electrically powered wheelchair K211647HP358EA Electrically Powered Wheelchair

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Dispositivos Relacionados (Código: ITI)

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Fonte oficial

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