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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, adjustable, mechanical
Regulation Description Mechanical chair.
Product CodeINN
Regulation Number 890.3100
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 11
Crack 6
Collapse 5
Bent 3
Buckled material 2
Product quality issue 2
Unstable 2
Component(s), broken 2
Detachment of device component 2
Disassembly 1
Entrapment of device or device component 1
Fracture 1
Mechanical issue 1
Normal 1
Use of Device Issue 1
Device Issue 1
Folding Issue 1
No Known Device Problem 1
No Information 1
Total Device Problems 45

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

Recalls
Manufacturer Recall Class Date Posted
1 Community Products, LLC III Dec-05-2008
2 Patterson Medical Holdings, Inc. II Sep-10-2009
3 Uplift Technologies Inc. II Nov-22-2011

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