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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, needle, diagnostic electromyograph
Regulation Description Diagnostic electromyograph needle electrode.
Product CodeIKT
Regulation Number 890.1385
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 2
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOTEST A/S
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
ROCHESTER ELECTRO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Lead(s), burn(s) from 3
Bent 2
Material separation 2
Other (for use when an appropriate device code cannot be identified) 1
Disinfection or Sterilization Issue at User Location 1
Dislodged or dislocated 1
Component(s), overheating of 1
Melted 1
Peeled 1
Total Device Problems 13

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 Chalgren Enterprises Inc II Sep-21-2010

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