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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device outpatient cardiac telemetry
Definition Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.
Product CodeQYX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED CARDIAC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIONET, INC
  SUBSTANTIALLY EQUIVALENT 1
CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
CORVENTIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH SERVICES, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Transmit Record 50 50
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Heart Problem 53 53
Insufficient Information 4 4

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