FDA 510(k)

Folding Mobility Scooter (KD101)

Número K: K252502 · 2025-10-06

RequerenteNanjing Kangni Smart Technology Co., Ltd.

Data da decisão2025-10-06

Código do produtoINI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Folding Mobility Scooter (KD101) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Kangni Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-06 under 510(k) number K252502. 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 Folding Mobility Scooter (KD101)?

Folding Mobility Scooter (KD101) is a medical device that received FDA 510(k) clearance on 2025-10-06. The listed applicant is Nanjing Kangni Smart Technology Co., Ltd.. The 510(k) number is K252502.

When did Folding Mobility Scooter (KD101) receive FDA 510(k) clearance?

Folding Mobility Scooter (KD101) received FDA 510(k) clearance on 2025-10-06, under 510(k) number K252502.

Who is the listed applicant for Folding Mobility Scooter (KD101)?

The FDA 510(k) record lists Nanjing Kangni Smart Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Folding Mobility Scooter (KD101)?

The FDA product code for Folding Mobility Scooter (KD101) is INI.

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Outros registros que listam Nanjing Kangni Smart Technology Co., Ltd. como candidato(a)

K252494Electrically powered wheelchair (KZ301B)

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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