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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, evoked response
Regulation Description Evoked response electrical stimulator.
Product CodeGWF
Regulation Number 882.1870
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AIRSEP CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 8
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 5
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 3
XLTEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 89
Inappropriate shock 8
No Known Device Problem 7
Electrical issue 4
No Information 3
Electro-magnetic interference (EMI) 2
Inadequate user interface 1
Failure to capture 1
Unintended energization 1
No display or display failure 1
Fracture 1
Overheating of device or device component 1
Unable to obtain readings 1
Device displays error message 1
Charging issue 1
Computer operating system issue 1
Total Device Problems 123

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 0 0 1 1 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alpine Biomed Aps II May-25-2013
2 Medtronic Xomed, Inc. II Sep-10-2012
3 Natus Medical Incorporated II Feb-09-2015
4 Nihon Kohden America Inc II Feb-17-2016

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