FDA 510(k)

Wheelchair

Número K: K163352 · 2017-07-28

RequerenteKunshan Hi-Fortune Health Products Co., Ltd.

Data da decisão2017-07-28

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2017-07-28 under 510(k) number K163352. 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 Wheelchair?

Wheelchair is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K163352.

When did Wheelchair receive FDA 510(k) clearance?

Wheelchair received FDA 510(k) clearance on 2017-07-28, under 510(k) number K163352.

Who is the listed applicant for 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 Wheelchair?

The FDA product code for Wheelchair is IOR.

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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 K212503HP458E Electrically Powered 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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