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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, isokinetic testing and evaluation
Regulation Description Isokinetic testing and evaluation system.
Product CodeIKK
Regulation Number 890.1925
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 4 4
2024 2 2
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 3 3
Melted 2 2
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Smoking 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Computer Software Problem 1 1
Unintended System Motion 1 1
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 8 8
Bone Fracture(s) 2 2
Impaired Healing 1 1
Atrial Fibrillation 1 1
Pain 1 1
Hyperextension 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Joint Laxity 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Trexo Robotics Holdings Inc. II Jul-25-2023
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