The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd. with the FDA for Electric Wheelchair (model: S7012).
| Device ID | K200857 |
| 510k Number | K200857 |
| Device Name: | Electric Wheelchair (Model: S7012) |
| Classification | Wheelchair, Powered |
| 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. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, CN 510663 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-12-17 |