510(k) Report

Devices descending from K012012

60 later devices reach Ecg Home through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042814ReadmyheartDailycare Biomedical, Inc.200559—
+2K162665MiCor A100 Wearable ECG RecorderMitac International Corp.20180—
+2K061123Palm Ecg Recorder, Model EP-201/202Parama-Tech Company., Ltd.20070—
+2K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc.20076—
+2K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc.200538—
+2K050620Readmyheart, Model RMH3.0Dailycare Biomedical, Inc.200510—
+3K172778CheckMyHeart PlusDailycare Biomedical, Inc.20180—
+3K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+3K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+3K112622Handheld Ecg MonitorBeijing Choice Electronic Technololgy Co., Ltd.20121—
+3K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.20112—
+3K111438REKA E100Reka Pte, Ltd.201132—
+3K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC20095—
+4K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc.20190—
+4K152863Portable ECG MonitorContec Medical Systems Co.,Ltd20160—
+4K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd.201331—
+4K121009Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc.20120—
+4K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC20104—
+5K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+5K213515WesperO2Wesper, Inc.20220—
+5K160956LD-Oxi systemLd Technology, LLC20162—
+5K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+5K130056Patient MonitorLd Technology, LLC20130—
+6K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+6K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+6K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+6K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+6K202456M5 RecorderGlobal Instrumentation, LLC20200—
+6K200141Oxi-W SystemLd Technology, LLC20201—
+6K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+6K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+6K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+6K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+7K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K253306BioTracker 2.0Biotracker, LLC20260—
+7K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+7K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+7K233584RhythmStar SystemRhythMedix, LLC20241—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+8K250793RhythmStar System (SL)RhythMedix, LLC20260—
+8K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+8K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+8K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+9K254255S-Patch CardioAIWellysis Corp.20260—
+9K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+9K233755HeartKey® RhythmB-Secur Limited20240—
+9K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+10K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+10K242129VitalRhythmVitalconnect, Inc.20250—
+10K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+10K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+11K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+11K253141DeepRhythmAIMedicalgorithmics S.A.20250—