Solax Electric Scooter

Vehicle, Motorized 3-wheeled

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 Solax Electric Scooter.

Pre-market Notification Details

Device IDK192190
510k NumberK192190
Device Name:Solax Electric Scooter
ClassificationVehicle, Motorized 3-wheeled
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. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou,  CN 510663
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-13
Decision Date2021-04-23

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