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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scale, patient
Product CodeFRW
Regulation Number 880.2720
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Detachment of Device or Device Component 1 1
Nonstandard Device 1 1
Naturally Worn 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Seca II Mar-03-2020
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