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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
2017 4 4
2018 4 4
2019 6 6
2020 1 1
2021 1 1
2022 1 1
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 4 4
Mechanical Problem 3 3
Device Operates Differently Than Expected 2 2
Unintended System Motion 2 2
Protective Measures Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Programming Issue 1 1
Self-Activation or Keying 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 7 7
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1
Discomfort 1 1
Injury 1 1
Fracture, Arm 1 1
Arthralgia 1 1
Loss of consciousness 1 1
No Patient Involvement 1 1
No Information 1 1
Insufficient Information 1 1
Bone Fracture(s) 1 1
Loss of Range of Motion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Full Vision Inc II Jun-30-2023
2 Full Vision Inc II Dec-03-2022
3 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Jul-16-2018
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