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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
Regulation Description Power traction equipment.
Product CodeITH
Regulation Number 890.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ERGO-FLEX TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXCITE MEDICAL OF TAMPA BAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2021 1 1
2023 1 1
2024 5 5
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4 4
Detachment of Device or Device Component 3 3
Unintended System Motion 3 3
Unintended Movement 2 2
Patient Device Interaction Problem 1 1
Key or Button Unresponsive/not Working 1 1
Insufficient Device Problem Information 1 1
Structural Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 2 2
Pain 2 2
Injury 1 1
Pressure Sore/Ulcer 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pivotal Health Solutions, Inc. II Jul-10-2024
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