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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device equipment, traction, powered
Regulation Description Power traction equipment.
Product CodeITH
Regulation Number 890.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
CERT HEALTH SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 2
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ENRAF-NONIUS B.V.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HILL LABORATORIES CO.
  SUBSTANTIALLY EQUIVALENT 1
ITO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
STL INTL
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 1
VAX-D MEDICAL TECHNOLOGIES USA, L.C.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Back Technologies, Inc. II Jun-05-2015
2 Mettler Electronics Corp II Jun-17-2011
3 Spinetronics, LLC II Apr-02-2012

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