510(k) Report

Devices descending from K953648

60 later devices reach A-V Impulse System Model 6060 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100—
+1K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.200718—
+1K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall200438—
+1K012597Sterilmed Reprocessed Compression SleevesSterilmed, Inc.20021—
+2K163055Reprocessed Kendall SCD Express Foot CuffCovidien20160—
+2K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.201314—
+2K112677The Venous Assist SystemDaesung Maref Co., Ltd.201210—
+2K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long20110—
+2K110977VesoflowCaremed Supply, Inc.20116—
+2K110358Venodyne V810Microtek Medical, Inc.20110—
+2K103247VascucompThermotek, Inc.20100—
+2K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC201011—
+2K102582Arterioflow Model 7500 Sequential Compression DeviceDevon Medical, Inc.20100—
+2K100306Kendall SCD Sequential Compression Comfort SleevesCovidien20100—
+2K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+2K060049Reprocessed Compression SleevesAlliance Medical Corp.20061—
+2K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063—
+3K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.20250—
+3K203417DVT-4000SDaesung Maref Co., Ltd.20210—
+3K203016DVT-2600Daesung Maref Co., Ltd.20201—
+3K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations201812—
+3K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd.20161—
+3K150980Venous Assist SystemDaesung Maref Co., Ltd.20161—
+3K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142—
+3K141064Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc.20144—
+3K123830Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd.20132—
+3K122873Vasopouse Deep Vein Thrombosis Compression Device Model Ipcs, Model SQSCaremed Supply, Inc.20130—
+3K122499Aircast Venaflow Elite SystemDjo, LLC20121—
+3K120944Kendall SCD 700 Sequential Compression ControllerCovidien20125—
+3K100909Reprocessed Compression SleevesAscent Healthcare Solutions201001
+3K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091—
+4K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.20260—
+4K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd20250—
+4K213577VenAir, Sequential Compression SystemApex Medical Corp.20221—
+4K213313Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd.20220—
+4K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20210—
+4K203353DVT-ProDaesung Maref Co., Ltd.20210—
+4K200154B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd.20201—
+4K191856Compression Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20200—
+4K193550Therm-XZenith Technical Innovations202010—
+4K190854Therm-XZenith Technical Innovations201911—
+4K181217VesoFlow Lite DVT Compression DeviceCaremed Supply, Inc.20180—
+4K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.20151—
+4K141390Intermittent Pneumatic Compression DeviceWuhan Landing Medical Hi-Tech, Ltd.20140—
+4K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc.20130—
+4K130722Aircast Venaflow Elite SystemDjo, LLC20130—
+4K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—
+5K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…Wellell, Inc.20250—
+5K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+5K223729FLOWpressoMedella Health Limited20233—
+5K231801MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited20230—
+5K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+5K231912Therm-XZenith Technical Innovations20231—
+5K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+5K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd.20160—
+6K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+6K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+6K240986Cold CompressionJkh Health Co., Ltd.20240—
+7K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+7K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—