FDA 510(k)

Powered Wheelchair (NXN20-208, NXN20-211)

Número K: K241603 · 2024-11-20

RequerenteZhejiang Nysin Medical Co., Ltd.

Data da decisão2024-11-20

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered Wheelchair (NXN20-208, NXN20-211) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K241603. 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 (NXN20-208, NXN20-211)?

Powered Wheelchair (NXN20-208, NXN20-211) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. The 510(k) number is K241603.

When did Powered Wheelchair (NXN20-208, NXN20-211) receive FDA 510(k) clearance?

Powered Wheelchair (NXN20-208, NXN20-211) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K241603.

Who is the listed applicant for Powered Wheelchair (NXN20-208, NXN20-211)?

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

What is the FDA product code for Powered Wheelchair (NXN20-208, NXN20-211)?

The FDA product code for Powered Wheelchair (NXN20-208, NXN20-211) is ITI.

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

K252275Electric Scooter (DDF100)K241529Powered Wheelchair (NXN20-209)K241379Powered Wheelchair (NXN20-205, NXN20-205M)

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.

Fonte oficial

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