The following data is part of a premarket notification filed by Jiangyin Newrise Medical Equipment Co., Ltd with the FDA for Manual Wheelchair.
| Device ID | K180852 |
| 510k Number | K180852 |
| Device Name: | Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Jiangyin Newrise Medical Equipment Co., Ltd No.97, WenXin Road, LinGang Street Jiangyin, CN 214400 |
| Contact | Huang Bing |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2019-03-01 |