• 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 stocking, medical support (to prevent pooling of blood in legs)
Regulation Description Medical support stocking.
Product CodeDWL
Regulation Number 880.5780
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
BSN
  SUBSTANTIALLY EQUIVALENT 2
E.C.I. USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K873280  ENHANCE SUPPORT HOSE
KNIT-RITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SSL
  SUBSTANTIALLY EQUIVALENT 1
TORBUT GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 18
Unknown (for use when the device problem is not known) 3
Positioning Issue 2
Unintended movement 1
No code available 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 26

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

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II May-10-2014

-
-