Electric Wheelchair (Model: S7110)

Wheelchair, Powered

Dongguan Prestige Sporting Goods Co., Ltd.

The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd. with the FDA for Electric Wheelchair (model: S7110).

Pre-market Notification Details

Device IDK200978
510k NumberK200978
Device Name:Electric Wheelchair (Model: S7110)
ClassificationWheelchair, Powered
Applicant Dongguan Prestige Sporting Goods Co., Ltd. 3rd Ind. District, Qiaotou Area, Houjie Town Dongguan,  CN 523950
ContactZhang Zhao
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510663
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2021-04-16

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