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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
Defective component 10
Bacterial contamination of device 6
Tipover 6
Detachment of device component 6
Unstable 6
Use of Device Issue 5
Leak 4
Maintenance does not comply to manufacturers recommendations 4
Unintended movement 4
Installation-related problem 3
No Known Device Problem 3
Mechanical issue 3
Inadequate training 2
Device inoperable 2
Device maintenance issue 2
Fracture 2
Component falling 2
Temperature issue 2
Positioning Issue 1
Dislodged or dislocated 1
Device Issue 1
Malfunction 1
Failure to disinfect 1
Incorrect display 1
Electrical issue 1
Fail-safe design failure 1
Loss of or failure to bond 1
Safety interlock(s) inadequate 1
Migration of device or device component 1
Misconnection 1
Normal 1
Total Device Problems 101

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