FDA 510(k)

Powered Mobility Scooter (PMS105, GUT177, GCAT047)

Número K: K252590 · 2025-11-21

RequerenteIntradin (Shanghai) Machinery Co., Ltd.

Data da decisão2025-11-21

Código do produtoINI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered Mobility Scooter (PMS105, GUT177, GCAT047) is the device name listed in this FDA 510(k) record. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K252590. 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 Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K252590.

When did Powered Mobility Scooter (PMS105, GUT177, GCAT047) receive FDA 510(k) clearance?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) received FDA 510(k) clearance on 2025-11-21, under 510(k) number K252590.

Who is the listed applicant for Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

The FDA 510(k) record lists Intradin (Shanghai) Machinery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

The FDA product code for Powered Mobility Scooter (PMS105, GUT177, GCAT047) is INI.

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Outros registros que listam Intradin (Shanghai) Machinery Co., Ltd. como candidato(a)

K243970Portable Wheelchair K250027Powered Mobility Scooter K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

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 K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

Fonte oficial

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