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FDA 510(k)

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)

Número K: K260937 · 2026-06-24

RequerenteShanghai Waylong Intelligent Technology Co.,Ltd
Data da decisão2026-06-24
Código do produtoITI
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Waylong Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260937. 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 Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Shanghai Waylong Intelligent Technology Co.,Ltd. The 510(k) number is K260937.

When did Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) receive FDA 510(k) clearance?

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260937.

Who is the listed applicant for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

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

What is the FDA product code for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

The FDA product code for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is ITI.

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Dispositivos Relacionados (Código: ITI)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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