SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

Sleeve, Limb, Compressible

Jiangsu Synecoun Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Synecoun Medical Technology Co., Ltd. with the FDA for Synecare 1100 Deep Vein Thrombosis Prevention Therapy System.

Pre-market Notification Details

Device IDK211937
510k NumberK211937
Device Name:SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
ClassificationSleeve, Limb, Compressible
Applicant Jiangsu Synecoun Medical Technology Co., Ltd. 1/2F East Side,No. 50, G60, Eastside Of Lujia Road, West of Koutai Road, China Medical City Taizhou,  CN 225300
ContactZhheng Li
CorrespondentIvy Wang
Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Century Avenue Shanghai,  CN 200122
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-22
Decision Date2021-11-18

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