510(k) Report

Devices descending from K010744

21 later devices reach Flowtron Universal, Model AC600 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141578Devon Cirona 6200 DVTDevon Medical20144—
+1K133119Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O.20142—
+1K130571Devon Cirona 6100 DVTDevon Medical, Inc.20136—
+1K110977VesoflowCaremed Supply, Inc.20116—
+1K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091—
+1K072372Phlebopress Model 601A Compression Therapy DeviceMego Afek20070—
+1K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+2K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20250—
+2K211253PlasmaWaveManamed, Inc.20210—
+2K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC20190—
+2K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd.20190—
+2K143438Flowtron ACS900Getinge (Suzhou) Co., Ltd.201511
+2K141064Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc.20144—
+2K131743Cirona DVT Foot GarmentDevon Medical, Inc.20130—
+2K122873Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQSCaremed Supply, Inc.20130—
+2K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—
+3K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.20260—
+3K200154B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd.20201—
+3K191937Ezvena IPC, Ezvena SQSEezcare Medical Corp20200—
+3K181217VesoFlow Lite DVT Compression DeviceCaremed Supply, Inc.20180—
+4K231801MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited20230—