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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device percussor, powered-electric
Regulation Description Powered percussor.
Product CodeBYI
Regulation Number 868.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED HOLDING CO.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 8
Increase in Pressure 4
Pressure Problem 1
Battery Problem 1
Total Device Problems 14

Recalls
Manufacturer Recall Class Date Posted
1 Aptalis Pharmatech Inc. II Jan-22-2015
2 HILL-ROM MANUFACTURING, INC. II Nov-30-2017

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