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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, electrocardiograph, telephone
Regulation Description Telephone electrocardiograph transmitter and receiver.
Product CodeDXH
Regulation Number 870.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 4
ECORDUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIVMOR
  SUBSTANTIALLY EQUIVALENT 1
NANOWEAR INC.
  SUBSTANTIALLY EQUIVALENT 2
QT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG CORECARE TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
VITALSIGNS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2022 6 6
2023 4 4
2024 2 2
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 7 7
Application Program Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Failure to Power Up 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Thermal Decomposition of Device 2 2
No Apparent Adverse Event 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
False Negative Result 1 1
Communication or Transmission Problem 1 1
Unintended Electrical Shock 1 1
Smoking 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
False Alarm 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Detachment of Device or Device Component 1 1
Excessive Heating 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Skin Inflammation/ Irritation 3 3
Chest Pain 3 3
Insufficient Information 3 3
Myocardial Infarction 2 2
High Blood Pressure/ Hypertension 1 1
Dysphasia 1 1
Weight Changes 1 1
Hypersensitivity/Allergic reaction 1 1
Tingling 1 1
Electric Shock 1 1
Shock from Patient Lead(s) 1 1
No Code Available 1 1
Dizziness 1 1
Abdominal Distention 1 1
Atrial Fibrillation 1 1
Itching Sensation 1 1
Burn, Thermal 1 1
Cognitive Changes 1 1
Cardiac Arrest 1 1
Skin Discoloration 1 1
Confusion/ Disorientation 1 1
Burning Sensation 1 1
Neck Pain 1 1
Erythema 1 1
Numbness 1 1
Pain 1 1
Scar Tissue 1 1
Tachycardia 1 1
Headache 1 1
Bruise/Contusion 1 1
Skin Burning Sensation 1 1
Decreased Appetite 1 1

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