Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device chair, with casters
Regulation Description Mechanical chair.
Product CodeINM
Regulation Number 890.3100
Device Class 1


Premarket Reviews
ManufacturerDecision
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
WINCO, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 9
Detachment of device component 8
Product quality issue 6
Tipover 5
Use of Device Issue 4
Fracture 3
No Known Device Problem 2
Defective component 2
Component(s), worn 2
Component(s), broken 2
Bent 1
Collapse 1
Crack 1
Fail-safe design failure 1
Device Issue 1
Structural problem 1
Reuse 1
Size incorrect for patient 1
Unstable 1
No Information 1
Hole in material 1
Folded 1
Buckled material 1
Total Device Problems 56

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 0 3 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Winco Mfg., LLC II Feb-04-2013
2 Winco Mfg., LLC II Oct-10-2012
3 Winco Mfg., LLC II Apr-25-2012
4 Winco Mfg., LLC II Feb-26-2012
5 Winco, Inc. II Oct-27-2010

-
-