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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device percussor, powered-electric
Regulation Description Powered percussor.
Product CodeBYI
Regulation Number 868.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED RESPIRATORY
  SUBSTANTIALLY EQUIVALENT 2
B & F MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GENERAL PHYSIOTHERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 12
No code available 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Aptalis Pharmatech Inc. II Jan-22-2015

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