• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device stretcher, wheeled, powered
Regulation Description Powered wheeled stretcher.
Product CodeINK
Regulation Number 890.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 3
Slippage of device or device component 3
Sticking 1
No Information 1
Detachment of device component 1
Unintended head motion 1
Leak 1
Total Device Problems 11

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 1 1 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Div. of Stryker Corporation II Aug-09-2010
2 Stryker Medical Division of Stryker Corporation II Mar-17-2016
3 Stryker Medical Division of Stryker Corporation II Aug-03-2011

-
-