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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrocardiograph software for over-the-counter use
Regulation Description Electrocardiograph software for over-the-counter use.
Definition An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
Product CodeQDA
Regulation Number 870.2345
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE INC.
  SUBSTANTIALLY EQUIVALENT 1
FITBIT, INC.
  SUBSTANTIALLY EQUIVALENT 1
GARMIN INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
WHOOP, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 3 3
2023 5 5
2024 14 14
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 1 1
Unintended Electrical Shock 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Product Quality Problem 1 1
Device Sensing Problem 1 1
Illegible Information 1 1
Missing Information 1 1
Appropriate Term/Code Not Available 1 1
Computer System Security Problem 1 1
Radiofrequency Interference (RFI) 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 8 8
Skin Inflammation/ Irritation 3 3
Hypersensitivity/Allergic reaction 2 2
Itching Sensation 2 2
Rash 2 2
Erythema 2 2
High Blood Pressure/ Hypertension 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Neuropathy 1 1
Arrhythmia 1 1
Skin Irritation 1 1
Breast Cancer 1 1
Fatigue 1 1
Nausea 1 1
Dizziness 1 1
Unspecified Musculoskeletal problem 1 1
Local Reaction 1 1
Discomfort 1 1
Vertigo 1 1
Numbness 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Tissue Breakdown 1 1
Low Blood Pressure/ Hypotension 1 1

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