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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device restraint, protective
Regulation Description Protective restraint.
Product CodeFMQ
Regulation Number 880.6760
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CHILDREN'S HEALTH FIRST, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  SUBSTANTIALLY EQUIVALENT 15
EM ADAMS
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 4
J. T. POSEY CO.
  SUBSTANTIALLY EQUIVALENT 9
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 7
  1.  K963360  MEDLINE BODY HOLDER
  2.  K963362  MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE T ...
  3.  K963378  MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CIN ...
  4.  K963404  MEDLINE PELVIC HOLDER
  5.  K963452  MEDLINE ZIPPER SLEEVED VEST
  6.  K963504  MEDLINE OPEN END FINGER CONTROL MITT
  7.  K963569  WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR ...
SKIL CARE
  SUBSTANTIALLY EQUIVALENT 12
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 39
Locking mechanism failure 20
Unknown (for use when the device problem is not known) 17
Break 17
Tears, rips, holes in device, device material 15
No code available 12
Item contaminated during manufacturing or shipping 11
Torn material 8
Component(s), broken 8
Detachment of device component 7
Device operates differently than expected 6
Close, difficult to 6
Use of Device Issue 6
Material separation 5
Material rupture 4
Material integrity issue 4
No Information 4
Defective component 3
Hole in material 3
Entrapment of device or device component 2
Slippage of device or device component 2
Unexpected therapeutic results 2
No Known Device Problem 2
Difficult to open or close 2
Detachment of device or device component 2
Out-of-box failure 1
Defective item 1
Loose 1
Misapplication 1
Device Difficult to Setup or Prepare 1
Total Device Problems 212

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 1 2 0 0 0 1 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Mar-14-2014
2 J T Posey Company II Apr-09-2013
3 J T Posey Company II Sep-22-2009
4 J T Posey Company II Feb-03-2009
5 J T Posey Company II Dec-02-2008
6 Med Tec Inc II Sep-14-2015
7 Med Tec Inc II Jan-15-2015

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