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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, suction, ward use, portable, ac-powered
Regulation Description Powered suction pump.
Product CodeJCX
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
AARDVARK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
Ding Hwa Co., Ltd.
  SUBSTANTIALLY EQUIVALENT 1
EMG
  SUBSTANTIALLY EQUIVALENT 3
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
KEYMED
  SUBSTANTIALLY EQUIVALENT 2
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHUCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 6
Component(s), broken 4
Disassembly 1
Filter, assembly 1
Fracture 1
Loose 1
Material rigid or stiff 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Pressure issue 1
Sediment, precipitate or deposit in device or device ingredient 1
Total Device Problems 19

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

Recalls
Manufacturer Recall Class Date Posted
1 Impact Instrumentation, Inc. III Sep-20-2012
2 KCI USA, Inc. II Sep-20-2008
3 Stryker Instruments Div. of Stryker Corporation II Dec-03-2012
4 Sunrise Medical II Feb-10-2009

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