510(k) Report

Devices descending from K043604

155 later devices reach Lifeshirt Real-Time with Vivomonitor Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113054EquivitalHidalgo Limited201271—
+1K100040BioharnessZephyr Technology Corporation20103—
+1K083287Avivo Mobile Patient Management SystemCorventis, Inc.200957—
+1K061993Equivital, Model EQ-01Hidalgo Limited200699—
+1K062338TelevisitPHD Medical20060—
+2K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+2K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+2K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+2K113045BioharnessZephyr Technology Corporation20122—
+2K121197Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc.201210—
+2K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+2K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+2K081140VisensiaObs Medical200822—
+3K193296eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc.20203—
+3K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+3K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+3K173248CardioskinBioserenity Sas20180—
+3K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+3K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+3K171244PhysiotraceNimbleheart, Inc.20170—
+3K161431SimplECGNanowear, Inc.20165—
+3K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+3K150992Vios Monitoring SystemVios Medical, Inc.20157—
+3K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+3K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+3K142087Cova Monitoring SystemTosense, Inc.20151—
+3K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+3K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+3K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+3K110953Visensia, Visensia with AlertObs Medical201117—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+4K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+4K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.20250—
+4K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited20221—
+4K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+4K201669SimpleSENSENanowear, Inc.20203—
+4K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+4K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+4K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+4K182532Liba3 SystemNational Cardiac, Inc.20190—
+4K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+4K173510BioStamp nPointMc10, Inc.20180—
+4K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+4K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+4K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+4K152491MoMe Software PlatformInfobionic, Inc.20150—
+4K131000V-Patch SystemIntelesens Limited20140—
+4K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+4K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.20250—
+5K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+5K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K241397HinscopeHinlab Sas20240—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+5K231276SmartCardia 7L PlatformSmartcardia SA20230—
+5K230386SpassageQSpass, Inc.20231—
+5K223073AlioAlio, Inc.20230—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K222550Current Health SystemCurrent Health, Ltd.20221—
+5K212160SimpleSENSE PlatformNanowear, Inc.20211—
+5K211305ANNE OneSibel, Inc.20216—
+5K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+5K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+5K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+5K191620Vitls PlatformVitls, Inc.20202—
+5K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+5K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+5K133701Nuvant MCT SystemCorventis, Inc.201423—
+6K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240558NavoycdsAlgodx AB20240—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—