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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transcranial magnetic stimulator
Regulation Description Repetitive transcranial magnetic stimulation system.
Definition A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Product CodeOBP
Regulation Number 882.5805
Device Class 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Neuronetics, Inc. II May-27-2009

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