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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K220671
Device Name Manual Wheelchair
Applicant
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd.
Zhongkuang S. Rd., High-Tech Development Zone,
Jing County
Hengshui,  CN 053599
Applicant Contact Liu Zhihao
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/07/2022
Decision Date 07/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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