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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, wheelchair
Regulation Description Wheelchair accessory.
Product CodeKNO
Regulation Number 890.3910
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRYOR PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SKIL CARE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 2
Material frayed 1
No code available 1
Improper or incorrect procedure or method 1
Loose 1
Total Device Problems 6

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 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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