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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cover, mattress (medical purposes)
Regulation Description Mattress cover for medical purposes.
Product CodeFMW
Regulation Number 880.6190
Device Class 1


Premarket Reviews
ManufacturerDecision
ADROIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION FABRICS GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Product quality issue 2
Use of Device Issue 1
No Known Device Problem 1
Total Device Problems 4

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 2 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II Sep-12-2010
2 Invacare Corporation II Sep-12-2010
3 Primus Medical LLC II Sep-09-2014

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