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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, muscle, powered, for muscle conditioning
Regulation Description Powered muscle stimulator.
Definition A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
Product CodeNGX
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
COMPEX S.A.
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
DOMINO S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRONIC WAVEFORM LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FAMIDOC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIGA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPORT-ELEC
  SUBSTANTIALLY EQUIVALENT 5
Well-Life Healthcare Limited
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Information 14
No Known Device Problem 9
Total Device Problems 23

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

Recalls
Manufacturer Recall Class Date Posted
1 Pinook-Usa II Nov-07-2013

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