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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, patient rotation, powered
Regulation Description Powered patient rotation bed.
Product CodeIKZ
Regulation Number 890.5225
Device Class 2


Premarket Reviews
ManufacturerDecision
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 2
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 8
No Known Device Problem 7
Device inoperable 7
Detachment of device component 5
Defective component 5
Device handling issue 5
No Information 3
Unintended system motion 3
Difficult to position 3
Product quality issue 2
Low audible alarm 2
Break 2
Disconnection 2
No display or display failure 2
Electrical issue 2
Fail-safe design failure 2
Difficult to open or close 2
Dislodged or dislocated 1
Torn material 1
Cut in material 1
Device displays error message 1
Patient-device incompatibility 1
Material frayed 1
Inflation issue 1
Mechanical issue 1
Misconnection 1
Defective Alarm 1
Failure to reset 1
Smoking 1
Device stops intermittently 1
System fails to activate 1
Total Device Problems 76

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arjo Hospital Equipment AB II Feb-27-2015
2 ArjoHuntleigh Inc. II Feb-04-2014
3 KCI USA, Inc. II May-10-2011
4 KCI USA, Inc. II Dec-13-2010

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