510(k) Report

Devices descending from K060146

30 later devices reach Activecare ++ System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model…Venous Health Systems, Inc.20123—
+1K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd.20128—
+1K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.20119—
+1K103113Vasculaire Compression SystemVenous Health Systems, Inc.20114—
+1K073028Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Venowave, Inc.20082—
+1K062818Flexitouch SystemTactile Systems Technology, Inc.200610—
+2K232640Venowave VW5Thermabright20240—
+2K211200WoundExpressHuntleigh Healthcare, Ltd.20210—
+2K192337ZerovenoDimedi Co., Ltd.20200—
+2K181651Radial Medical Compression SystemRadial Medical, Inc.20181—
+2K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20168—
+2K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd.20147—
+2K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc.20130—
+2K120972Flexitouch SystemTactile Systems Technology, Inc.20129—
+3K203052Movement and Compressions System (the MAC System)Recovery Force, LLC20210—
+3K190976Radial Medical Compression SystemRadial Medical, Inc.20190—
+3K170216Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20177—
+3K162481RF1400 Active Compression WrapRecovery Force, LLC20172—
+3K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142—
+4K232300ElastiMed SACSElastimed, Ltd.20231—
+4K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20205—
+4K193288Koya RippleKoya, Inc.20205—
+4K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.20151—
+5K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical20260—
+5K243177Sacs ProElastimed, Ltd.20240—
+5K223228DayspringKoya Medical, Inc.20241—
+5K210885DayspringKoya Medical, Inc.20214—
+5K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd.20160—
+6K222823AeroDVx Arm SystemSun Scientific, Inc.20230—
+6K212287Dayspring LiteKoya Medical, Inc.20210—