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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diathermy, shortwave, for use in applying therapeutic deep heat
Regulation Description Shortwave diathermy.
Product CodeIMJ
Regulation Number 890.5290
Device Class 2


Premarket Reviews
ManufacturerDecision
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 2
ITO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  1

Device Problems
Loose or intermittent connection 1
Total Device Problems 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 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DJO, LLC II Oct-15-2015

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