FDA 510(k)

Electric Wheelchair (XW-LY001)

Número K: K200423 · 2021-09-22

RequerenteYongkang Dingchang Industry & Trade Co., Ltd.

Data da decisão2021-09-22

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Wheelchair (XW-LY001) is the device name listed in this FDA 510(k) record. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K200423. 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 (XW-LY001)?

Electric Wheelchair (XW-LY001) is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. The 510(k) number is K200423.

When did Electric Wheelchair (XW-LY001) receive FDA 510(k) clearance?

Electric Wheelchair (XW-LY001) received FDA 510(k) clearance on 2021-09-22, under 510(k) number K200423.

Who is the listed applicant for Electric Wheelchair (XW-LY001)?

The FDA 510(k) record lists Yongkang Dingchang Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (XW-LY001)?

The FDA product code for Electric Wheelchair (XW-LY001) is ITI.

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