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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stretcher, hand-carried
Regulation Description Hand-carried stretcher.
Product CodeFPP
Regulation Number 880.6900
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 1
PRISM
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K940130  STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER

Device Problems
Break 7
Unintended movement 2
Bent 2
No Information 1
Detachment of device component 1
Unintended system motion 1
Pallet break 1
Slippage of device or device component 1
Device inoperable 1
Component missing 1
Detachment of device or device component 1
Device operates differently than expected 1
Naturally worn 1
Total Device Problems 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Paramed Systems II Dec-28-2009
2 Stryker Medical Div. of Stryker Corporation II Nov-09-2009
3 Stryker Medical Div. of Stryker Corporation II Feb-04-2009
4 Stryker Medical Division of Stryker Corporation II Feb-06-2012
5 Stryker Medical Division of Stryker Corporation II Aug-11-2011

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