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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, non-measuring
Regulation Description Nonmeasuring exercise equipment.
Product CodeION
Regulation Number 890.5370
Device Class 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 5 5
2023 2 3
2024 1 1
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 6 6
Adverse Event Without Identified Device or Use Problem 2 2
Device Slipped 1 1
Material Split, Cut or Torn 1 1
Break 1 2
Crack 1 1
Insufficient Information 1 1
Defective Component 1 1
Use of Device Problem 1 1
Loose or Intermittent Connection 1 2
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Limb Fracture 2 2
Pneumothorax 1 1
Joint Dislocation 1 1
Emotional Changes 1 1
Multiple Fractures 1 1
Foreign Body In Patient 1 1
Erythema 1 1
Loss of Range of Motion 1 1
Fall 1 1
Pain 1 1
Hemorrhage/Bleeding 1 2

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