510(k) Report

Devices descending from K043423

101 later devices reach Model SC-3008 Sequential Circulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150953Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OCBio Compression Systems, Inc.20151—
+1K142640Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model…Bio Compression Systems, Inc.20147—
+1K110276Powerpress UnitHanuri Distribution, Inc.20110—
+1K100446Circuflow 5100 Sequential Compression DeviceDevon Medical, Inc.201022—
+1K071763Amadeus Adaptive Compression TherapyConvatec20080—
+1K053225Cellu M6 Keymodule ILpg One, Inc.20063—
+1K062818Flexitouch SystemTactile Systems Technology, Inc.200610—
+1K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.200652—
+1K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc.200622—
+2K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+2K210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…Bio Compression Systems, Inc.20212—
+2K200353ManaFlowManamed, Inc.20201—
+2K190854Therm-XZenith Technical Innovations201911—
+2K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations201812—
+2K171685Med4 EliteCool Systems, Inc. (Dba Game Ready)201721—
+2K171793Sequential Circulator SC-2004FC-OCBio Compression Systems, Inc.20170—
+2K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20168—
+2K131306IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression DeviceBio Compression Systems, Inc.20132—
+2K123959Circuflow 5150Devon Medical, Inc.20136—
+2K122640VpulseCothera, LLC20130—
+2K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc.201312—
+2K120972Flexitouch SystemTactile Systems Technology, Inc.20129—
+2K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long20110—
+2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.201125—
+2K103247VascucompThermotek, Inc.20100—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100—
+2K101523Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc.201021—
+2K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.200718—
+3K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.20260—
+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—
+3K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC20250—
+3K242754ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O.20251—
+3K240011Lymphedema CompressionJkh Health Co., Ltd.20240—
+3K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+3K203746Venen-trainer (Model: FM150, SFM90)Shenzhen Pango Electronic Co., Ltd.20210—
+3K193079ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris20210—
+3K193550Therm-XZenith Technical Innovations202010—
+3K183702Polar Care WaveBreg, Inc.20193—
+3K183631medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP20193—
+3K180248VascuEase IC-1200-WHBio Compression Systems, Inc.20181—
+3K172779AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20182—
+3K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20183—
+3K172030Devon 51Devon Medical Products (Jiangsu), Ltd.20170—
+3K170216Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20177—
+3K143185entré Model PD08-UTactile Systems Technology, Inc.20154—
+3K133274Vena ProInnovamed Health, LLC201422—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc.201314—
+3K130174Dvtcare CA5Ossur Americas, Inc.20132—
+3K102582Arterioflow Model 7500 Sequential Compression DeviceDevon Medical, Inc.20100—
+4K254217AerloomEvolym, LLC20260—
+4K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.20260—
+4K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.20250—
+4K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+4K242940Xrecovery (XR-001)Shenzhen Xinrun Electric Appliances Co, Ltd.20240—
+4K234155Nimbl (model PD08-N1)Tactile Medical20240—
+4K240986Cold CompressionJkh Health Co., Ltd.20240—
+4K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.20240—
+4K223729FLOWpressoMedella Health Limited20233—
+4K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+4K231912Therm-XZenith Technical Innovations20231—
+4K221654medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP20220—
+4K213097Armory MotionPain Management Technologies, Inc.20220—
+4K212287Dayspring LiteKoya Medical, Inc.20210—
+4K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20211—
+4K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20205—
+4K200285VenaOneVena Group, LLC20201—
+4K193288Koya RippleKoya, Inc.20205—
+4K200564Aria SystemInova Labs20200—
+4K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC20192—
+4K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20192—
+4K193068AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20191—
+4K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+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—
+5K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical20260—
+5K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+5K223228DayspringKoya Medical, Inc.20241—
+5K223193AIROS 8P Sequential Compression DeviceAiros Medical, Inc.20220—
+5K223195AIROS 6P Sequential Compression DeviceAiros Medical, Inc.20221—
+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—
+5K211200WoundExpressHuntleigh Healthcare, Ltd.20210—
+5K211253PlasmaWaveManamed, Inc.20210—
+5K210885DayspringKoya Medical, Inc.20214—
+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—
+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—
+6K251086PnueAira (PNCU-01)Biotab, LLC20250—
+6K222823AeroDVx Arm SystemSun Scientific, Inc.20230—
+6K183349AeroDVx SystemSun Scientific, Inc.20190—