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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vibrator, therapeutic
Regulation Description Therapeutic vibrator.
Product CodeIRO
Regulation Number 890.5975
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL PHYSIOTHERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 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 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Non-Invasive Monitoring Systems, Inc. II Jun-18-2012

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