FDA 510(k)

Powered Wheelchair (PL001-9001)

Número K: K252829 · 2025-11-12

RequerenteSuzhou KD Intelligent Device Co., Ltd.

Data da decisão2025-11-12

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered Wheelchair (PL001-9001) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou KD Intelligent Device Co., Ltd.. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K252829. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Powered Wheelchair (PL001-9001)?

Powered Wheelchair (PL001-9001) is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Suzhou KD Intelligent Device Co., Ltd.. The 510(k) number is K252829.

When did Powered Wheelchair (PL001-9001) receive FDA 510(k) clearance?

Powered Wheelchair (PL001-9001) received FDA 510(k) clearance on 2025-11-12, under 510(k) number K252829.

Who is the listed applicant for Powered Wheelchair (PL001-9001)?

The FDA 510(k) record lists Suzhou KD Intelligent Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Wheelchair (PL001-9001)?

The FDA product code for Powered Wheelchair (PL001-9001) is ITI.

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Dispositivos Relacionados (Código: ITI)

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