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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device treadmill, powered
Product CodeIOL
Regulation Number 890.5380
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 1 1
2022 1 1
2023 6 6
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 3 3
Mechanical Problem 2 2
Protective Measures Problem 2 2
Unintended System Motion 2 2
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Emits Odor 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 6 6
Bone Fracture(s) 3 3
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Fatigue 1 1
Hematoma 1 1
Multiple Fractures 1 1
Abrasion 1 1
Injury 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
Loss of consciousness 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Full Vision Inc II Jun-30-2023
2 Full Vision Inc II Dec-03-2022
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