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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transport, patient, powered
Regulation Description Powered patient transport.
Product CodeILK
Regulation Number 890.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
BRUNO INDEPENDENT LIVING AIDS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ELECTRIC MOBILITY CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOVEROUND CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 2
Device handling issue 1
Improper or incorrect procedure or method 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 0 0 2 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Aug-22-2012
2 ThyssenKrupp Access Corp II Dec-18-2012

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