FDA 510(k)

Power wheelchair (N6101)

Número K: K241686 · 2024-08-13

RequerenteZhejiang Zhonglei Medical Technology Co. , Ltd.

Data da decisão2024-08-13

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Power wheelchair (N6101) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Zhonglei Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241686. 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 Power wheelchair (N6101)?

Power wheelchair (N6101) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Zhejiang Zhonglei Medical Technology Co. , Ltd.. The 510(k) number is K241686.

When did Power wheelchair (N6101) receive FDA 510(k) clearance?

Power wheelchair (N6101) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241686.

Who is the listed applicant for Power wheelchair (N6101)?

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

What is the FDA product code for Power wheelchair (N6101)?

The FDA product code for Power wheelchair (N6101) is ITI.

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Outros registros que listam Zhejiang Zhonglei Medical Technology Co. , Ltd. como candidato(a)

K242308Power wheelchair K242402Power wheelchair

Dispositivos Relacionados (Código: ITI)

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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