The following data is part of a premarket notification filed by Kunshan Hi-fortune Health Products Co., Ltd. with the FDA for Hp458e Electrically Powered Wheelchair.
| Device ID | K212503 |
| 510k Number | K212503 |
| Device Name: | HP458E Electrically Powered Wheelchair |
| Classification | Wheelchair, Powered |
| Applicant | Kunshan Hi-Fortune Health Products Co., Ltd. No. 625, Juxiang Road, Zhangpu Town Kunshan, CN 215321 |
| Contact | Jianjiang Fan |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, East Lujiazui 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 | 2021-08-09 |
| Decision Date | 2022-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973852594581 | K212503 | 000 |