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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device components, wheelchair
Regulation Description Wheelchair component.
Product CodeKNN
Regulation Number 890.3920
Device Class 1


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROHO, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Product quality issue 2
Device alarm system issue 1
Total Device Problems 5

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Permobil Inc II Mar-22-2012

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