The following data is part of a premarket notification filed by Hebei Ruilangde Medical Equipment Technology Group Co., Ltd with the FDA for Manual Wheelchair.
| Device ID | K220671 |
| 510k Number | K220671 |
| Device Name: | Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd Zhongkuang South Road, High-end Technology Industrial Development Zone, Jing County Hengshui, CN 053599 |
| Contact | Liu Zhizhao |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-07-21 |