SyneCare 1000 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 1000 Deep Vein Thrombosis Prevention Therapy System.

Pre-market Notification Details

Device IDK203310
510k NumberK203310
Device Name:SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
ClassificationSleeve, Limb, Compressible
Applicant Jiangsu Synecoun Medical Technology Co., Ltd. East Of 1/F. No. 50, G60, Eastside Of Lujia Road, Westside of Koutai Road. CMC Taizhou,  CN 225316
ContactYue Li
CorrespondentYue Li
Jiangsu Synecoun Medical Technology Co., Ltd. East Of 1/F. No. 50, G60, Eastside Of Lujia Road, Westside of Koutai Road. CMC Taizhou,  CN 225316
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-10
Decision Date2021-04-02

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