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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, transcutaneous, for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Product CodeGZJ
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AVAZZIA, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXELGAARD MFG
  SUBSTANTIALLY EQUIVALENT 1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 20
BIO-RESEARCH ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 5
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
ELECTRONIC WAVEFORM LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 17
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 4
HELIO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HENLEY
  SUBSTANTIALLY EQUIVALENT 1
INTELSOURCE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 3
KATECHO, INC.
  SUBSTANTIALLY EQUIVALENT 3
KOALATY PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MED-LECTRIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 10
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PEPIN MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
REHABILICARE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 2
SELECTIVE MED COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIAN JA MEEI ENTERPRISE
  SUBSTANTIALLY EQUIVALENT 2
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 3
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 1
TUNG FU ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
Well-Life Healthcare Limited
  SUBSTANTIALLY EQUIVALENT 2
XANACARE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 16
Temperature issue 8
Charred 7
Inappropriate shock 2
No Information 2
Device operates differently than expected 1
Electronic property issue 1
Human-Device Interface Issue 1
Incompatibility problem 1
Material Protrusion 1
Circuit Failure 1
Overheating of device or device component 1
Burn of device or device component 1
Burst 1
Total Device Problems 44

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

Recalls
Manufacturer Recall Class Date Posted
1 Avazzia, Inc III Sep-01-2007
2 Neuro Resource Group Inc II Apr-28-2011
3 Synaptic Corp II Apr-19-2012

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