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FDA 510(k)

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

K-Number: K211937 · 2021-11-18

ApplicantJiangsu Synecoun Medical Technology Co., Ltd.
Decision Date2021-11-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Synecoun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K211937. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Jiangsu Synecoun Medical Technology Co., Ltd.. The 510(k) number is K211937.

When did SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System receive FDA 510(k) clearance?

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System received FDA 510(k) clearance on 2021-11-18, under 510(k) number K211937.

Who is the listed applicant for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

The FDA 510(k) record lists Jiangsu Synecoun Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System?

The FDA product code for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is JOW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03195777Novel PET/CT and Treatment Strategies to Reduce PTS Following DVTCOMPLETEDNCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITINGNCT07665320Impedance Plethysmography Based Deep Vein Thrombosis Monitoring During Catheter-directed ThrombolysisRECRUITINGNCT07762222Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous UlcersRECRUITINGNCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITINGNCT05491109Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke PatientsCOMPLETED

Other records listing Jiangsu Synecoun Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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