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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, non-direct patient interface (home-use)
Regulation Description Therapeutic humidifier for home use.
Product CodeKFZ
Regulation Number 868.5460
Device Class 1


Premarket Reviews
ManufacturerDecision
KAZ, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fire 8
No Known Device Problem 3
Smoking 3
Burn of device or device component 3
Melted 2
Device handling issue 1
Improper or incorrect procedure or method 1
Spark 1
Human-Device Interface Issue 1
Total Device Problems 23

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

Recalls
Manufacturer Recall Class Date Posted
1 Bigwall Enterprises II Feb-25-2016

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