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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electromyograph, diagnostic
Regulation Description Diagnostic electromyograph.
Product CodeIKN
Regulation Number 890.1375
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FASSTECH
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device-device incompatibility 7
Device operates differently than expected 4
Incompatibility problem 1
No Known Device Problem 1
Electrode(s), failure of 1
Loose or intermittent connection 1
Sensing intermittently 1
Invalid sensing 1
Total Device Problems 17

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 1 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 SpineMatrix Inc II Jun-30-2010

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