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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device exerciser, powered
Regulation Description Powered exercise equipment.
Product CodeBXB
Regulation Number 890.5380
Device Class 1


Premarket Reviews
ManufacturerDecision
BALTIMORE THERAPEUTIC EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 3
BIODEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DEVELOPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 5
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 2
VITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 6
Detachment of device or device component 5
Mechanics altered 5
No Known Device Problem 2
Use of Device Issue 2
Device handling issue 2
Detachment of device component 1
Crack 1
Unintended movement 1
Instruction for use issue 1
Increase in pressure 1
Incorrect software programming calculations 1
Total Device Problems 28

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

Recalls
Manufacturer Recall Class Date Posted
1 Accelerated Care Plus Corporation II Jul-31-2013
2 Alter-G, Incorporated II Aug-16-2011
3 BioMotion Medical Systems, LLC II Dec-20-2012
4 Hocoma AG II Jan-07-2010

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