The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd. with the FDA for Solax Electric Scooter (models: S3023, S3024, S3025, S3026).
| Device ID | K191897 |
| 510k Number | K191897 |
| Device Name: | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) |
| 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 Biologcial 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 | 2019-07-16 |
| Decision Date | 2021-02-10 |