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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
Regulation Description Ultrasound and muscle stimulator.
Product CodeIMG
Regulation Number 890.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA TECH MEDICAL SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  1
  SUBSTANTIALLY EQUIVALENT 12
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ELMED
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 3
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
NAIMCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANT MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 1
No Information 1
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Chattanooga Corp Inc II Aug-06-2008

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