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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, heating, powered
Regulation Description Powered heating pad.
Product CodeIRT
Regulation Number 890.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
BATTLE CREEK MANUFACTURERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
P&G, THE GILLETTE COMPANY
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Spark 147
Malfunction 59
Burn hole(s) 18
Use of Device Issue 14
Charred 11
Burn of device or device component 3
Electrical issue 3
No Known Device Problem 1
Overheating of device or device component 1
No Information 1
Fire 1
Hole in material 1
Component(s), overheating of 1
Total Device Problems 261

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

Recalls
Manufacturer Recall Class Date Posted
1 HoMedics, Inc. I Mar-21-2007

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