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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
treadmill, powered
Product Code
IOL
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
Multiple Fractures
1
1
Hematoma
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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