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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, hydro-massage
Regulation Description Immersion hydrobath.
Product CodeILJ
Regulation Number 890.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ARJO
  SUBSTANTIALLY EQUIVALENT 2
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 2
JOERNS HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
P&G, THE GILLETTE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VANCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 16
Unstable 6
Bacterial contamination of device 5
Detachment of device component 5
Unintended movement 4
Use of Device Issue 3
Mechanical issue 3
Inadequate training 2
Device inoperable 2
Defective component 2
Fracture 2
Device maintenance issue 2
Temperature issue 2
Tipover 2
Installation-related problem 2
Maintenance does not comply to manufacturers recommendations 1
No Known Device Problem 1
Positioning Issue 1
Loss of or failure to bond 1
Leak 1
Failure to disinfect 1
Fail-safe design failure 1
Malfunction 1
Misconnection 1
Normal 1
Total Device Problems 68

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