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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, cutaneous
Regulation Description Cutaneous electrode.
Product CodeGXY
Regulation Number 882.1320
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 6
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 2
ASPECT
  SUBSTANTIALLY EQUIVALENT 9
AXELGAARD MFG
  SUBSTANTIALLY EQUIVALENT 8
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
D.O. WEAVER
  SUBSTANTIALLY EQUIVALENT 1
DURDEN ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
EMPI
  SUBSTANTIALLY EQUIVALENT 10
ENRAF-NONIUS B.V.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT HEARING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
KATECHO, INC.
  SUBSTANTIALLY EQUIVALENT 4
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICOTEST A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 10
NAIMCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 2
PEPIN MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHESTER ELECTRO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RUDOLF STORZ GMBH
  SUBSTANTIALLY EQUIVALENT 1
SELECTIVE MED COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 2
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1
VERMONT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISION QUEST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
Well-Life Healthcare Limited
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device-device incompatibility 8
No Known Device Problem 5
Device operates differently than expected 4
Incompatibility problem 3
Impedance issue 2
Incorrect or inadequate result 2
Improper or incorrect procedure or method 1
Unknown (for use when the device problem is not known) 1
Failure to deliver 1
Break 1
Chemical reaction 1
Electrode contact(s), problem with 1
Energy output to patient tissue incorrect 1
High impedance 1
Needle, separation 1
Total Device Problems 33

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 1 1 1 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Axiobionics, LLC II Aug-01-2011
2 Covidien LLC dba Uni-Patch II Dec-10-2012
3 International Rehabilitative Sciences, Inc. II Jun-26-2015
4 Medtronic Navigation, Inc. II May-09-2014
5 NAImco Inc dba Richmar Inc II Feb-14-2013
6 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Jan-26-2012

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