Electric Wheelchair (XW-LY001)

Wheelchair, Powered

Yongkang Dingchang Industry & Trade Co., LTD.

The following data is part of a premarket notification filed by Yongkang Dingchang Industry & Trade Co., Ltd. with the FDA for Electric Wheelchair (xw-ly001).

Pre-market Notification Details

Device IDK200423
510k NumberK200423
Device Name:Electric Wheelchair (XW-LY001)
ClassificationWheelchair, Powered
Applicant Yongkang Dingchang Industry & Trade Co., LTD. NO.99 Huaxi Road, Xicheng Street Yongkang,  CN 321300
ContactTony Chen
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2021-09-22

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