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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, flotation therapy, non-powered
Regulation Description Nonpowered flotation therapy mattress.
Product CodeIKY
Regulation Number 880.5150
Device Class 1


Premarket Reviews
ManufacturerDecision
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material integrity issue 58
Break 53
Fracture 52
Use of Device Issue 50
Maintenance does not comply to manufacturers recommendations 47
No Known Device Problem 6
Delamination 5
Degraded 5
Inflation issue 3
Installation-related problem 3
Dislodged or dislocated 2
Device operates differently than expected 2
Defective component 2
Leak 2
Decrease in pressure 1
Disconnection 1
Electrical issue 1
Device or device component damaged by another device 1
Electrical shorting 1
Total Device Problems 295

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 0 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 Mar-06-2015
2 KCI USA, Inc. II Jan-25-2010
3 Stryker Medical Division of Stryker Corporation II May-23-2011

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