510(k) Report

Devices descending from K071130

61 later devices reach Heartrak AF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20135—
+1K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20127—
+1K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+1K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+2K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.20180—
+2K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+2K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A.20153—
+2K141813Rhythmstar SystemRhythMedix, LLC20148—
+2K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+2K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+2K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+2K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+3K233584RhythmStar SystemRhythMedix, LLC20241—
+3K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+3K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.20200—
+3K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+3K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+3K172311BioFlux DeviceBiotricity, Inc.20171—
+3K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+3K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+3K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+3K142087Cova Monitoring SystemTosense, Inc.20151—
+3K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+3K131000V-Patch SystemIntelesens Limited20140—
+3K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+3K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+4K250793RhythmStar System (SL)RhythMedix, LLC20260—
+4K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+4K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+4K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+4K231276SmartCardia 7L PlatformSmartcardia SA20230—
+4K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K161431SimplECGNanowear, Inc.20165—
+4K133701Nuvant MCT SystemCorventis, Inc.201423—
+5K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+5K231620Nuubo SmartSmart Solutions Technologies SL20230—
+5K201669SimpleSENSENanowear, Inc.20203—
+5K173248CardioskinBioserenity Sas20180—
+5K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+5K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+6K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+6K212160SimpleSENSE PlatformNanowear, Inc.20211—
+6K182532Liba3 SystemNational Cardiac, Inc.20190—
+6K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+7K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+7K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+8K254255S-Patch CardioAIWellysis Corp.20260—
+8K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+8K233755HeartKey® RhythmB-Secur Limited20240—
+8K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+9K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+9K242129VitalRhythmVitalconnect, Inc.20250—
+9K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+9K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+10K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+10K253141DeepRhythmAIMedicalgorithmics S.A.20250—