• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Bacterial contamination of device 17
Break 16
Defective component 10
Tipover 6
Detachment of device component 6
Component falling 6
Unstable 6
Use of Device Issue 5
Unintended movement 5
Maintenance does not comply to manufacturers recommendations 4
No Known Device Problem 4
Leak 4
Mechanical issue 3
Installation-related problem 3
Temperature issue 2
Chemical spillage 2
Inadequate training 2
Device inoperable 2
Device maintenance issue 2
Fracture 2
Inability to irrigate 1
Failure to disinfect 1
Incorrect display 1
Electrical issue 1
Fail-safe design failure 1
Safety interlock(s) inadequate 1
Migration of device or device component 1
Misconnection 1
Normal 1
Device Contamination with biological material 1
Device operates differently than expected 1
Dislodged or dislocated 1
Loss of or failure to bond 1
Device Issue 1
Malfunction 1
Positioning Issue 1
No Information 1
Total Device Problems 124

-
-