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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, isokinetic testing and evaluation
Regulation Description Isokinetic testing and evaluation system.
Product CodeIKK
Regulation Number 890.1925
Device Class 2


Premarket Reviews
ManufacturerDecision
BALTIMORE THERAPEUTIC EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
BIODEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CYBEX
  SUBSTANTIALLY EQUIVALENT 7
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 2
Device handling issue 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Interactive Motion Technologies, Inc. II Nov-02-2015
2 MedX Holdings, Inc. II Jan-07-2015

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