The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd with the FDA for Solax Powered Wheelchair (models: S7101, S7103).
| Device ID | K182400 |
| 510k Number | K182400 |
| Device Name: | Solax Powered Wheelchair (Models: S7101, S7103) |
| Classification | Wheelchair, Powered |
| Applicant | Dongguan Prestige Sporting Goods Co., Ltd 3rd Ind. District, Qiatou 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2020-04-14 |