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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
2016 7 7
2017 2 2
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 3 3
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Break 2 2
Mechanical Problem 1 1
Loss of Power 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Temperature Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Pressure Sores 1 1
Neck Pain 1 1
Hematoma 1 1
Skin Discoloration 1 1
Bruise/Contusion 1 1
Edema 1 1
Pain 1 1
Tissue Damage 1 1
Discomfort 1 1
Injury 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hocoma AG II Jun-23-2020
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