• 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 device, iontophoresis, other uses
Regulation Description Iontophoresis device.
Product CodeEGJ
Regulation Number 890.5525
Device Class 2


Premarket Reviews
ManufacturerDecision
AA ADVANCED TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
AXELGAARD MFG
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 2
  SUBSTANTIALLY EQUIVALENT 9
ERCHONIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IOMED, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT 8
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICROLAB AMERICAS INC
  SUBSTANTIALLY EQUIVALENT 1
NAIMCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTH COAST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEPIN MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
SELECTIVE MED COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
WR MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1

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 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


-
-