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FDA 510(k)

K5 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))

N.º K: K260319 · 2026-03-31

Fecha de decisión2026-03-31
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

K5 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)) 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 2026-03-31 under 510(k) number K260319. 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 K5 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))?

K5 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)) is a medical device that received FDA 510(k) clearance on 2026-03-31. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K260319.

When did K5 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)) receive FDA 510(k) clearance?

K5 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)) received FDA 510(k) clearance on 2026-03-31, under 510(k) number K260319.

Who is the listed applicant for K5 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))?

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 K5 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))?

The FDA product code for K5 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)) is IOR.

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

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Dispositivos relacionados (Código: IOR)

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Fuente oficial

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