FDA 510(k)

Zhenjiang Assure Mechanical Wheelchair,model:K1

Número K: K231320 · 2023-06-05

RequerenteZhenjiang Assure Medical Equipment Co., Ltd.

Data da decisão2023-06-05

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zhenjiang Assure Mechanical Wheelchair,model:K1 is the device name listed in this FDA 510(k) record. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K231320. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Zhenjiang Assure Mechanical Wheelchair,model:K1?

Zhenjiang Assure Mechanical Wheelchair,model:K1 is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K231320.

When did Zhenjiang Assure Mechanical Wheelchair,model:K1 receive FDA 510(k) clearance?

Zhenjiang Assure Mechanical Wheelchair,model:K1 received FDA 510(k) clearance on 2023-06-05, under 510(k) number K231320.

Who is the listed applicant for Zhenjiang Assure Mechanical Wheelchair,model:K1?

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

What is the FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1?

The FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1 is IOR.

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Outros registros que listam Zhenjiang Assure Medical Equipment Co., Ltd. como candidato(a)

K261919Multifunctional wheelchair (YJ-059)K260144Reclining wheelchair (YJ-013L)K260145YJ-K1K2 Wheelchair (YJ-013F)K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))K251159Power wheelchair

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Dispositivos Relacionados (Código: IOR)

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH K261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fonte oficial

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