FDA 510(k)

Powered Wheelchair

Número K: K212854 · 2022-01-10

RequerenteZhejiang Qianxi Vehicle Co., Ltd.

Data da decisão2022-01-10

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Qianxi Vehicle Co., Ltd.. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212854. 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 Powered Wheelchair?

Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Zhejiang Qianxi Vehicle Co., Ltd.. The 510(k) number is K212854.

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

Powered Wheelchair received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212854.

Who is the listed applicant for Powered Wheelchair?

The FDA 510(k) record lists Zhejiang Qianxi Vehicle Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Wheelchair?

The FDA product code for Powered Wheelchair is ITI.

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Dispositivos Relacionados (Código: ITI)

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