510(k) Report

Devices descending from K981311

88 later devices reach Cowboy XV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150806PulseFlowDFPulseflow Technologies20150—
+1K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model…Venous Health Systems, Inc.20123—
+1K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100—
+1K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.200652—
+1K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+1K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.200136
+1K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.200031—
+2K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+2K190854Therm-XZenith Technical Innovations201911—
+2K181651Radial Medical Compression SystemRadial Medical, Inc.20181—
+2K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations201812—
+2K171685Med4 EliteCool Systems, Inc. (Dba Game Ready)201721—
+2K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc.20130—
+2K122640VpulseCothera, LLC20130—
+2K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long20110—
+2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.201125—
+2K103247VascucompThermotek, Inc.20100—
+2K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100—
+2K100909Reprocessed Compression SleevesAscent Healthcare Solutions201001
+2K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.200611
+2K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.2006301
+3K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE Saúde20260—
+3K252386Hot and Cold Compression System (A02-C-032)Chengdu Cryo-Push Medical Technology Co.,Ltd20260—
+3K242754ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O.20251—
+3K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+3K193079ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris20210—
+3K193550Therm-XZenith Technical Innovations202010—
+3K190976Radial Medical Compression SystemRadial Medical, Inc.20190—
+3K183702Polar Care WaveBreg, Inc.20193—
+3K133274Vena ProInnovamed Health, LLC201422—
+3K130174Dvtcare CA5Ossur Americas, Inc.20132—
+3K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd.20128—
+3K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.20119—
+3K103113Vasculaire Compression SystemVenous Health Systems, Inc.20114—
+3K073028Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Venowave, Inc.20082—
+3K062818Flexitouch SystemTactile Systems Technology, Inc.200610—
+4K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.20260—
+4K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+4K242940Xrecovery (XR-001)Shenzhen Xinrun Electric Appliances Co, Ltd.20240—
+4K232640Venowave VW5Thermabright20240—
+4K240986Cold CompressionJkh Health Co., Ltd.20240—
+4K223729FLOWpressoMedella Health Limited20233—
+4K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+4K231912Therm-XZenith Technical Innovations20231—
+4K213097Armory MotionPain Management Technologies, Inc.20220—
+4K211200WoundExpressHuntleigh Healthcare, Ltd.20210—
+4K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20211—
+4K200285VenaOneVena Group, LLC20201—
+4K192337ZerovenoDimedi Co., Ltd.20200—
+4K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC20192—
+4K180248VascuEase IC-1200-WHBio Compression Systems, Inc.20181—
+4K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20168—
+4K160318PlasmaFlowManamed, Inc.20164—
+4K151158ALP VasQcare Take Home SystemCurrie Medical Specialties, Inc.20150—
+4K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products20155—
+4K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142—
+4K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd.20147—
+4K120972Flexitouch SystemTactile Systems Technology, Inc.20129—
+5K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+5K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.20240—
+5K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20210—
+5K212731Circul8 ProOrtho8, Inc.20210—
+5K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc.20210—
+5K211253PlasmaWaveManamed, Inc.20210—
+5K203052Movement and Compressions System (the MAC System)Recovery Force, LLC20210—
+5K200353ManaFlowManamed, Inc.20201—
+5K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing, Ltd.20200—
+5K191107PlexusAlleva Medical (D.G), Ltd.20190—
+5K180389Venera 508 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20181—
+5K170814Devon 24Devon Medical Products (Jiangsu), Ltd.20170—
+5K170216Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20177—
+5K162481RF1400 Active Compression WrapRecovery Force, LLC20172—
+5K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.20151—
+6K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+6K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—
+6K240011Lymphedema CompressionJkh Health Co., Ltd.20240—
+6K232300ElastiMed SACSElastimed, Ltd.20231—
+6K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20205—
+6K193288Koya RippleKoya, Inc.20205—
+6K183349AeroDVx SystemSun Scientific, Inc.20190—
+6K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd.20160—
+7K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical20260—
+7K243177Sacs ProElastimed, Ltd.20240—
+7K223228DayspringKoya Medical, Inc.20241—
+7K210885DayspringKoya Medical, Inc.20214—
+8K222823AeroDVx Arm SystemSun Scientific, Inc.20230—
+8K212287Dayspring LiteKoya Medical, Inc.20210—