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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, skin pressure
Regulation Description Skin pressure protectors.
Product CodeFMP
Regulation Number 880.6450
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
Action Products Incorporated
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  1.  K771519  SPECIALIST ARM & LEG PROTECTOR
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1
SPENCO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 7
No Known Device Problem 5
Not Applicable 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 15

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 2 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jan-06-2016
2 Childrens Medical Ventures I Aug-20-2014
3 Philips Medical Systems, Inc. I Dec-16-2014

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