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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aid, transfer
Regulation Description Daily activity assist device.
Product CodeIKX
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 50 50
2023 12 12
2024 7 7
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 47 47
Break 7 7
Mechanical Problem 7 7
Insufficient Information 7 7
Adverse Event Without Identified Device or Use Problem 2 2
Entrapment of Device 1 1
Crack 1 1
Collapse 1 1
Device Fell 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Human-Device Interface Problem 1 1
Deformation Due to Compressive Stress 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
Insufficient Information 4 4
Physical Entrapment 4 4
Bone Fracture(s) 3 3
Fall 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Joint Dislocation 1 1
Unspecified Musculoskeletal problem 1 1
Abrasion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Concussion 1 1
Pain 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NOA Medical Industries Inc II Jan-10-2025
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