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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photoplethysmograph analysis software for over-the-counter use
Regulation Description Photoplethysmograph analysis software for over-the-counter use.
Definition A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Product CodeQDB
Regulation Number 870.2790
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE, INC.
  SUBSTANTIALLY EQUIVALENT 3
FITBIT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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