Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, thermal regulating
Regulation Description Thermal regulating system.
Product CodeDWJ
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ADROIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARIZANT HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 3
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 12
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 11
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DYNATHERM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
GERATHERM MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
GVP ELETTRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INDITHERM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
MEDCOOL INC
  SUBSTANTIALLY EQUIVALENT 1
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MTRE ADVANCED TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 6
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
SEABROOK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 30
Smoking 8
Fluid leak 6
Tubing, incorrect placement of 4
Patient-device incompatibility 3
Component(s), overheating of 2
Leak 2
Method, improper/incorrect 2
Overheating of device or device component 2
Loose or intermittent connection 1
Melted 1
Fail-safe design failure 1
Fire 1
Insufficient heating 1
Excessive cooling 1
Human-Device Interface Issue 1
Inadequate user interface 1
No Information 1
Alarm, failure of warning 1
Total Device Problems 69

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 2 5 4 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arizant Inc II Mar-01-2010
2 Cincinnati Sub-Zero Products Inc II May-24-2012
3 Cincinnati Sub-Zero Products Inc II Feb-07-2012
4 Cincinnati Sub-Zero Products Inc II Sep-01-2011
5 Cincinnati Sub-Zero Products Inc II Jul-27-2011
6 Cincinnati Sub-Zero Products Inc II Jul-14-2011
7 Cincinnati Sub-Zero Products Inc II Jul-01-2011
8 Cincinnati Sub-Zero Products Inc II Mar-30-2011
9 Cincinnati Sub-Zero Products Inc II Feb-04-2010
10 Cincinnati Sub-Zero Products Inc II Oct-29-2009
11 Kimberly-Clark Corporation II Nov-29-2012
12 Kimberly-Clark Corporation II Aug-09-2012

-
-