The following data is part of a premarket notification filed by Silver Fox Corporation Limited with the FDA for Electric Wheelchair, Model: 9000n.
| Device ID | K221799 |
| 510k Number | K221799 |
| Device Name: | Electric Wheelchair, Model: 9000N |
| Classification | Wheelchair, Powered |
| Applicant | Silver Fox Corporation Limited No. 18, 1st TongLe Road, TongLe Industrial Zone TangXia Town PengJiang District, JiangMen Guangdong, CN |
| Contact | Chen Yan |
| Correspondent | Iris Fung Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN 510000 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-09-16 |