The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd with the FDA for Solax Electric Scooter (model: S202261b).
Device ID | K202549 |
510k Number | K202549 |
Device Name: | Solax Electric Scooter (Model: S202261B) |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | Dongguan Prestige Sporting Goods Co., Ltd 3rd Ind. District, Qiaotou Area, Houjie Town Dongguan, CN 523950 |
Contact | Zhang Zhao |
Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, CN 510663 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-03 |
Decision Date | 2021-02-26 |