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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cushion, flotation
Regulation Description Flotation cushion.
Product CodeKIC
Regulation Number 890.3175
Device Class 1


Premarket Reviews
ManufacturerDecision
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROHO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKIL CARE
  SUBSTANTIALLY EQUIVALENT 1
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 6
Break 2
Use of Device Issue 2
Device operates differently than expected 1
Hole in material 1
Inadequate storage 1
No Information 1
Total Device Problems 14

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roho Inc. II Apr-05-2017

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