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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device treadmill, powered
Regulation Description Powered exercise equipment.
Product CodeIOL
Regulation Number 890.5380
Device Class 1


Premarket Reviews
ManufacturerDecision
BATTLE CREEK MANUFACTURERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNISEN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Electrical issue 1
No code available 1
Total Device Problems 3

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 1 0 0 0 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AlterG, Incorporated II Mar-04-2014
2 Cardiac Science Corporation II Jun-04-2010
3 GE Healthcare II Jun-22-2015
4 GE Healthcare II Mar-17-2015

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