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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K211937
Device Name SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Applicant
Jiangsu Synecoun Medical Technology Co., Ltd.
1/2f E. Side,# 50, G60, Eastside Of Lujia Rd., W.
Of Koutai Rd., China Medical City
Taizhou,  CN 225300
Applicant Contact Zhheng Li
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/22/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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