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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, transfer
Regulation Description Daily activity assist device.
Product CodeIKX
Regulation Number 890.5050
Device Class 1

Device Problems
Break 83
Use of Device Issue 28
Detachment of device component 21
Buckled material 18
Product quality issue 16
Collapse 15
Bent 12
No Known Device Problem 11
Crack 10
Inaccurate delivery 6
Other (for use when an appropriate device code cannot be identified) 6
Detachment of device or device component 5
Unstable 5
Fracture 4
Inadequate training 3
User used incorrect product for intended use 3
Material separation 3
Device Issue 2
Folded 2
Fluid leak 2
Slippage of device or device component 2
Defective component 2
Improper or incorrect procedure or method 2
Melted 2
Unknown (for use when the device problem is not known) 1
Connector pin failure 1
Solder joint failure 1
Material integrity issue 1
Device operates differently than expected 1
No Information 1
Torn material 1
Mechanical issue 1
Out-of-box failure 1
Misassembled by Users 1
Device handling issue 1
Difficult to fold or unfold 1
Shaft break 1
Fitting problem 1
Total Device Problems 277

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 0 0 1 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AliMed Corporation II Jan-22-2009
2 Handicare USA, Inc. II Oct-24-2016
3 Handicare USA, Inc. II May-14-2015
4 North Coast Medical Inc II Apr-16-2012
5 Nutech Manufacturing Corp II Dec-01-2009
6 Zimmer Inc. II Sep-16-2008

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