The following data is part of a premarket notification filed by Kunshan Hi-fortune Health Products Co.,ltd. with the FDA for Wheelchair.
| Device ID | K163352 |
| 510k Number | K163352 |
| Device Name: | Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Kunshan Hi-Fortune Health Products Co.,Ltd. No. 301, Qinhe Road, Zhangpu Town Kunshan, CN 215300 |
| Contact | Hongfa Zhi |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. Liyuan Town, Tongzhou District, Beijing, CN 101121 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-07-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WHEELCHAIR 81045528 1045528 Dead/Cancelled |
National Paraplegia Foundation 0000-00-00 |