510(k) Report

Devices descending from K963725

210 later devices reach Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083174HealthepodCard Guard Scientific Survival, Ltd.200915—
+1K071228Fidelity 200 Cardiac Event RecorderSignalife, Inc.200732—
+1K012012Ecg HomeH&C Medical Devices Spa200260—
+1K012223CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd.2001181—
+1K994009CG-2100 Ecg TransmitterCard Guard Scientific Survival, Ltd.19990—
+2K170181PrizmaG-Medical Innovations, Ltd.20171—
+2K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd.201331—
+2K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+2K063044Cardiobelt Electrode BeltMonebo Technologies, Inc.200718—
+2K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc.200647—
+2K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd.200599—
+2K042814ReadmyheartDailycare Biomedical, Inc.200559—
+2K040942VST3Biowatch Medical, Inc.200418—
+3K173589PrizmaG-Medical Innovations, Ltd.20180—
+3K162665MiCor A100 Wearable ECG RecorderMitac International Corp.20180—
+3K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+3K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+3K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+3K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC20147—
+3K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+3K122184Ecg CheckCardiac Designs, LLC201330—
+3K113045BioharnessZephyr Technology Corporation20122—
+3K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K100383Vitaphone. Model 100 BTVitasystems GmbH20101—
+3K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+3K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+3K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd.200717—
+3K061123Palm Ecg Recorder, Model EP-201/202Parama-Tech Company., Ltd.20070—
+3K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc.20076—
+3K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd.200644—
+3K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH20062—
+3K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc.200538—
+3K050620Readmyheart, Model RMH3.0Dailycare Biomedical, Inc.200510—
+3K050853PMP4 SpiroproCard Guard Scientific Survival, Ltd.20052—
+4K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+4K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+4K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+4K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+4K201456Scan MonitorWithings SA202161
+4K202456M5 RecorderGlobal Instrumentation, LLC20200—
+4K173872FibriCheckQompium NV20186—
+4K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+4K172778CheckMyHeart PlusDailycare Biomedical, Inc.20180—
+4K170506ECG Check - Universal, ECG Check - Universal PlusCardiac Designs, Inc.20170—
+4K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+4K171244PhysiotraceNimbleheart, Inc.20170—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+4K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+4K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+4K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+4K151027zensor systemIntelesens Limited20150—
+4K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH20150—
+4K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+4K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+4K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+4K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+4K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+4K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+4K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+4K121617SensicardiacDiacoustic Medical (Pty)201210—
+4K112622Handheld Ecg MonitorBeijing Choice Electronic Technololgy Co., Ltd.20121—
+4K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.20112—
+4K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+4K111438REKA E100Reka Pte, Ltd.201132—
+4K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+4K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+4K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+4K091579Foresee HomeNotal Vision, Ltd.20094—
+4K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC20095—
+4K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+4K080047Cardiosen'cShl Telemedicine International, Ltd.200811—
+4K072722Meddorna Wireless PRN Spirometer 100Meddorna, LLC20080—
+4K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2007252
+4K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd.20060—
+5K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+5K243305Masimo W1Masimo Corporation20250—
+5K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K232804FibriCheckQompium NV20241—
+5K232512Masimo W1Masimo Corporation20232—
+5K230812Withings Scan Monitor 2.0Withings20230—
+5K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+5K231620Nuubo SmartSmart Solutions Technologies SL20230—
+5K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+5K221260CSF-3Cardiacsense20231—
+5K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+5K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+5K201208Halo AF Detection SystemLivmor20200—
+5K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+5K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+5K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+5K183319Triangle SystemAliveCor, Inc.20193—
+5K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+5K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.20190—
+5K182040Coala Heart MonitorCoala Life AB20190—