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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, biofeedback
Regulation Description Biofeedback device.
Product CodeHCC
Regulation Number 882.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
FASSTECH
  SUBSTANTIALLY EQUIVALENT 5
LEXICOR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
REGULATORY STRATEGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
THOUGHT TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 14

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

Recalls
Manufacturer Recall Class Date Posted
1 EEG Info II Dec-17-2012
2 Powers Medical Devices, LLC II Dec-08-2015

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