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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, flotation therapy, powered
Regulation Description Powered flotation therapy bed.
Product CodeIOQ
Regulation Number 890.5170
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 7
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
LUMEX
  SUBSTANTIALLY EQUIVALENT 1
NUMOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 3
Therapeutic or diagnostic output failure 2
No Information 2
Inflation issue 2
Installation error 1
Leak 1
Mechanical issue 1
Slippage of device or device component 1
Burn of device or device component 1
Detachment of device component 1
Component falling 1
Use of Incorrect Control Settings 1
Unintended ejection 1
Device handling issue 1
Installation-related problem 1
No Known Device Problem 1
Pressure issue 1
Total Device Problems 22

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 1 1 1 1 1 3 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom Manufacturing, Inc. II Feb-15-2011
2 Hill-Rom Manufacturing, Inc. II Aug-03-2009
3 Hill-Rom Manufacturing, Inc. II Oct-07-2008
4 Hill-Rom, Inc. II Jul-23-2013
5 Hill-Rom, Inc. II Mar-14-2013
6 KCI USA, Inc. II Nov-20-2012
7 KCI USA, Inc. II Jan-25-2010
8 Stryker Medical Division of Stryker Corporation II Aug-09-2013

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