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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scale, patient
Regulation Description Patient scale.
Product CodeFRW
Regulation Number 880.2720
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 2 2
2024 1 1
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 5 5
Break 2 2
Overheating of Device 2 2
Flare or Flash 1 1
Calibration Problem 1 1
Fracture 1 1
Inaccurate Information 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Burning Sensation 1 1

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