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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 87
Use of Device Issue 30
Detachment of device component 21
Buckled material 18
Product quality issue 16
Collapse 15
Bent 12
No Known Device Problem 11
Crack 10
Other (for use when an appropriate device code cannot be identified) 6
Inaccurate delivery 6
Detachment of device or device component 5
Fracture 5
Unstable 5
Inadequate training 3
User used incorrect product for intended use 3
Material separation 3
Device Issue 3
Folded 2
Defective component 2
Improper or incorrect procedure or method 2
Melted 2
Slippage of device or device component 2
Fluid leak 2
Difficult to fold or unfold 1
Mechanical issue 1
Connector pin failure 1
Shaft break 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Out-of-box failure 1
Solder joint failure 1
Device operates differently than expected 1
Material integrity issue 1
Torn material 1
Misassembled by Users 1
No Information 1
Device handling issue 1
Total Device Problems 285

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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