The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods., Ltd. with the FDA for Solax Electric Scooter, Models: S302121, S302131, S302141, S302151.
Device ID | K172440 |
510k Number | K172440 |
Device Name: | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | Dongguan Prestige Sporting Goods., 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 | 2017-08-11 |
Decision Date | 2018-07-13 |
Summary: | summary |