FDA 510(k)

Multifunctional wheelchair (YJ-059)

Número K: K261919 · 2026-09-16

RequerenteZhenjiang Assure Medical Equipment Co., Ltd.

Data da decisão2026-09-16

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multifunctional wheelchair (YJ-059) 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 2026-09-16 under 510(k) number K261919. 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 Multifunctional wheelchair (YJ-059)?

Multifunctional wheelchair (YJ-059) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K261919.

When did Multifunctional wheelchair (YJ-059) receive FDA 510(k) clearance?

Multifunctional wheelchair (YJ-059) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261919.

Who is the listed applicant for Multifunctional wheelchair (YJ-059)?

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 Multifunctional wheelchair (YJ-059)?

The FDA product code for Multifunctional wheelchair (YJ-059) is IOR.

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

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 K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: IOR)

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH K260145YJ-K1K2 Wheelchair (YJ-013F)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.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair Mission

Fonte oficial

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