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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device massager, powered inflatable tube
Regulation Description Powered inflatable tube massager.
Product CodeIRP
Regulation Number 890.5650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
COOLSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON SEIMITSU SOKKI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TACTILE SYSTEMS TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
WONJIN MUSAN CO., LTD
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Failure to auto stop 2
No Known Device Problem 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 CoolSystems, Inc. III Sep-14-2011

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