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FDA 510(k)

Powered wheelchair (mobility robot) (M4, M4U)

Número K: K242358 · 2025-04-03

RequerenteXsto Co., Ltd.
Data da decisão2025-04-03
Código do produtoITI
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered wheelchair (mobility robot) (M4, M4U) is the device name listed in this FDA 510(k) record. The listed applicant is Xsto Co., Ltd.. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K242358. 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 (mobility robot) (M4, M4U)?

Powered wheelchair (mobility robot) (M4, M4U) is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Xsto Co., Ltd.. The 510(k) number is K242358.

When did Powered wheelchair (mobility robot) (M4, M4U) receive FDA 510(k) clearance?

Powered wheelchair (mobility robot) (M4, M4U) received FDA 510(k) clearance on 2025-04-03, under 510(k) number K242358.

Who is the listed applicant for Powered wheelchair (mobility robot) (M4, M4U)?

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

What is the FDA product code for Powered wheelchair (mobility robot) (M4, M4U)?

The FDA product code for Powered wheelchair (mobility robot) (M4, M4U) is ITI.

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