• 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 chair, positioning, electric
Regulation Description Electric positioning chair.
Product CodeINO
Regulation Number 890.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTIMATE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DESIGN SPECIFIC LTD
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
LUMEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MERITS
  SUBSTANTIALLY EQUIVALENT 1
PENOX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PIVOT ASSIST, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 4
WINCO, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 16
Device operates differently than expected 3
Smoking 3
Use of Device Issue 1
Defective item 1
Battery issue 1
Material Protrusion 1
Break 1
Collapse 1
Fire 1
Mechanical issue 1
Device emits odor 1
Unintended system motion 1
Overheating of device or device component 1
Product quality issue 1
Self-activation or keying 1
Total Device Problems 35

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

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II Aug-17-2013

-
-