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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ultrasonic diathermy for use in applying therapeutic deep heat
Regulation Description Ultrasonic diathermy.
Product CodeIMI
Regulation Number 890.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 8
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HENLEY
  SUBSTANTIALLY EQUIVALENT 1
HILL LABORATORIES CO.
  SUBSTANTIALLY EQUIVALENT 1
ITO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MATRIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 8
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 7
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 9
S.O.R. INTERNACIONAL, S.A.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  1

Device Problems
No Known Device Problem 2
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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