FDA 510(k)

Mobility Scooter (W3465, W3902 (S50 Carbon))

Número K: K260094 · 2026-08-10

RequerenteZhejiang Innuovo Rehabilitation Devices Co.,Ltd

Data da decisão2026-08-10

Código do produtoINI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mobility Scooter (W3465, W3902 (S50 Carbon)) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K260094. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mobility Scooter (W3465, W3902 (S50 Carbon))?

Mobility Scooter (W3465, W3902 (S50 Carbon)) is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K260094.

When did Mobility Scooter (W3465, W3902 (S50 Carbon)) receive FDA 510(k) clearance?

Mobility Scooter (W3465, W3902 (S50 Carbon)) received FDA 510(k) clearance on 2026-08-10, under 510(k) number K260094.

Quem é o solicitante listado para o Scooter de Mobilidade (W3465, W3902 (S50 Carbon))?

The FDA 510(k) record lists Zhejiang Innuovo Rehabilitation Devices Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility Scooter (W3465, W3902 (S50 Carbon))?

The FDA product code for Mobility Scooter (W3465, W3902 (S50 Carbon)) is INI.

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Outros registros que listam Zhejiang Innuovo Rehabilitation Devices Co.,Ltd como candidato(a)

K260176Mobility Scooter (W3483, W3483A)K253812Power Wheelchair (W5915B, W5915C, W5915D)K260056Power Wheelchair (N5515A, N5516, N5517A, N5519)K253806Power Wheelchair (N5919 series)K242471Cadeira de Rodas Elétrica (W5538)K242387Mobility Scooter (N3473)

Ver todos os 20 dispositivos →

Dispositivos Relacionados (Código: INI)

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)Jiangsu Intco Medical Products Co., Ltd.

Fonte oficial

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