The following data is part of a premarket notification filed by Yongkang Dingchang Industry & Trade Co., Ltd. with the FDA for Electric Wheelchair (xw-ly001).
| Device ID | K200423 |
| 510k Number | K200423 |
| Device Name: | Electric Wheelchair (XW-LY001) |
| Classification | Wheelchair, Powered |
| Applicant | Yongkang Dingchang Industry & Trade Co., LTD. NO.99 Huaxi Road, Xicheng Street Yongkang, CN 321300 |
| Contact | Tony Chen |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2021-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975991680033 | K200423 | 000 |
| 06975991680026 | K200423 | 000 |
| 06976477180047 | K200423 | 000 |
| 06976477180009 | K200423 | 000 |