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 Name:||Manual Wheelchair|
|Applicant||Hebei Ruilangde Medical Equipment Technology Group Co., Ltd Zhongkuang South Road, High-end Technology Industrial Development Zone, Jing County Hengshui, CN 053599|
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122
|CFR Regulation Number||890.3850 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|