Manual Wheelchair

Wheelchair, Mechanical

Hebei Ruilangde Medical Equipment Technology Group Co., Ltd

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.

Pre-market Notification Details

Device IDK220671
510k NumberK220671
Device Name:Manual Wheelchair
ClassificationWheelchair, Mechanical
Applicant Hebei Ruilangde Medical Equipment Technology Group Co., Ltd Zhongkuang South Road, High-end Technology Industrial Development Zone, Jing County Hengshui,  CN 053599
ContactLiu Zhizhao
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-07
Decision Date2022-07-21

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