FDA 510(k)

Electric Wheelchair (Model P2)

Número K: K252428 · 2025-09-18

Data da decisão2025-09-18

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Wheelchair (Model P2) is the device name listed in this FDA 510(k) record. The listed applicant is Superpi Robot Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K252428. 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 Electric Wheelchair (Model P2)?

Electric Wheelchair (Model P2) is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Superpi Robot Co., Ltd.. The 510(k) number is K252428.

When did Electric Wheelchair (Model P2) receive FDA 510(k) clearance?

Electric Wheelchair (Model P2) received FDA 510(k) clearance on 2025-09-18, under 510(k) number K252428.

Who is the listed applicant for Electric Wheelchair (Model P2)?

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

What is the FDA product code for Electric Wheelchair (Model P2)?

The FDA product code for Electric Wheelchair (Model P2) is ITI.

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