FDA.reportPublic FDA data

Electrocardiograph, home-use

Definition
A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.
GUDID devices
32
Last updated
2026-07-17 21:58:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L MaxAlivecor, Inc.AC-0192020-05-01
00810113577166Vive PrecisionVIVE HEALTH LLCDMD1091BLK2024-09-04
03700546708435Withings®WITHINGSWBS08-Black2023-08-30
03700546708442Withings®WITHINGSWBS08-White2023-08-30
04719872980018QT ECGQt Medical, Inc.QTERD1002018-12-01
04719872980889QT ECGQt Medical, Inc.QTERD1002022-12-19
04719872981503QT ECGQt Medical, Inc.QTERD1002023-06-08
04719872981527QT ECGQt Medical, Inc.QTERD1002024-07-08
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.3.32025-12-09
00860012964819WHOOP ECG FeatureWhoop, Inc.1.x2025-06-10
04719872981756QT ECGQt Medical, Inc.QTERD1002025-05-12
00812324000297GEMS Mobile ECGCardioComm Solutions, IncGM2025-03-20
06934440102069CheckmeShenzhen Viatom Technology Co.,Ltd.BP2 Blood Pressure Monitor2024-12-24
06934440102212Wellue/ViatomShenzhen Viatom Technology Co.,Ltd.BP2 Blood Pressure Monitor2024-12-24
06934440102588LEPU MEDICALShenzhen Viatom Technology Co.,Ltd.BP2 Blood Pressure Monitor2024-12-24
06934440102618BP2 Blood Pressure MonitorShenzhen Viatom Technology Co.,Ltd.BP2 Blood Pressure Monitor2024-12-24
00840241600313ASSURE Wearable ECGKestra Medical Technologies, Inc.80553-0012024-09-18
00840241600320Battery Kestra Medical Technologies, Inc.80499-0032024-09-18
00840241600337System CableKestra Medical Technologies, Inc.80500-0032024-09-18
10810113577163Vive PrecisionVIVE HEALTH LLCDMD1091BLK2024-09-04
00862887000319TelePatch Cardiac MonitorMEDICOMP, INC.PM8002024-07-24
04719872981534QT ECGQt Medical, Inc.QTERD1002024-07-08
00862887000388TelePatch Cardiac MonitorMEDICOMP, INC.PM7502023-09-25
13700546708432Withings®WITHINGSWBS08-Black2023-08-30
13700546708449Withings®WITHINGSWBS08-White2023-08-30
07290008960267RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTERSHL TELEMEDICINE INTERNATIONAL LTD.E-560-0 / E-561-02023-08-22
07290008960250CardioSen'CSHL TELEMEDICINE INTERNATIONAL LTD.4.22023-08-21
04719872981510QT ECGQt Medical, Inc.QTERD1002023-06-08
04719872980896QT ECGQt Medical, Inc.QTERD1002022-12-19
00860003939734AfibAlert / hom ecg+LOHMAN TECHNOLOGIES, LLCV2.02022-09-27
00810038852720 Fitbit Irregular Rhythm NotificationsFitbit LLCFB6042022-04-25
06934440100850WellueShenzhen Viatom Technology Co.,Ltd.BP2 Blood Pressure Monitor2021-07-30