FDA 510(k)

YJ-K1K2 Wheelchair (YJ-013F)

N.º K: K260145 · 2026-09-15

SolicitanteZhenjiang Assure Medical Equipment Co., Ltd.

Fecha de decisión2026-09-15

Código de productoIOR

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

YJ-K1K2 Wheelchair (YJ-013F) 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 2026-09-15 under 510(k) number K260145. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the YJ-K1K2 Wheelchair (YJ-013F)?

YJ-K1K2 Wheelchair (YJ-013F) is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K260145.

When did YJ-K1K2 Wheelchair (YJ-013F) receive FDA 510(k) clearance?

YJ-K1K2 Wheelchair (YJ-013F) received FDA 510(k) clearance on 2026-09-15, under 510(k) number K260145.

Who is the listed applicant for YJ-K1K2 Wheelchair (YJ-013F)?

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 YJ-K1K2 Wheelchair (YJ-013F)?

The FDA product code for YJ-K1K2 Wheelchair (YJ-013F) is IOR.

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Otros registros que enlistan a Zhenjiang Assure Medical Equipment Co., Ltd. como solicitante

K261919Multifunctional wheelchair (YJ-059)K260144Reclining wheelchair (YJ-013L)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 los 10 dispositivos →

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.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair Mission

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.