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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
  1.  K963463  STRAIT JACKET
  2.  K963464  RESTRAINT NET
  3.  K963465  PELVIC HOLDER
  4.  K963466  PEDIATRIC LIMB HOLDER
  5.  K963467  ROLL BELTS
  6.  K963468  RESTRICTIVE LIMB HOLDER
  7.  K963469  MITTENS
  8.  K963470  CRISS-CROSS VEST RESTRAINT
  9.  K963471  SUPER SECURITY RESTRAINT
  10.  K963472  PEDIATRIC VEST RESTRAINT
  11.  K963473  REUSABLE LIMB HOLDER
  12.  K963474  TUXEDO VEST RESTRAINT
  13.  K963476  DISPOSABLE LIMB HOLDER
  14.  K963477  PEDIATRIC MITTENS
  15.  K963478  SLEEVED/SLEEVELESS VEST RESTRAINT
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
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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