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TPLC
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Device
equipment, traction, powered
Product Code
ITH
Regulation Number
890.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
ERGO-FLEX TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER MEDIZINSYSTEME GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5
5
2021
1
1
2023
1
1
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
3
3
Mechanical Problem
2
2
Unintended System Motion
2
2
Use of Incorrect Control/Treatment Settings
1
1
Unintended Movement
1
1
Key or Button Unresponsive/not Working
1
1
Patient Device Interaction Problem
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4
4
No Known Impact Or Consequence To Patient
2
2
No Patient Involvement
2
2
Injury
1
1
Insufficient Information
1
1
Pain
1
1
Pressure Sores
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Pivotal Health Solutions, Inc.
II
Jul-10-2024
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