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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, cranial electrotherapy
Regulation Description Cranial electrotherapy stimulator.
Product CodeJXK
Regulation Number 882.5800
Device Class 3


Premarket Reviews
ManufacturerDecision
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electro-magnetic interference (EMI) 2
No Information 2
No Known Device Problem 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Health Directions, Inc III Sep-26-2007
2 Neuro-Fitness LLC II Apr-08-2008

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