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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device equipment, traction, powered
Product CodeITH
Regulation Number 890.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
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

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2
Unintended System Motion 2 2
Retraction Problem 1 1
Unintended Movement 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Pain 1 1
Injury 1 1

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