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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, measuring
Regulation Description Measuring exercise equipment.
Product CodeISD
Regulation Number 890.5360
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 4 4
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 3 3
Overheating of Device 2 2
Circuit Failure 1 1
Moisture Damage 1 1
Use of Device Problem 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Limb Fracture 4 4
Insufficient Information 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

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