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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
Regulation Description Powered muscle stimulator.
Product CodeIPF
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIODEX MEDICAL
  1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 7
CEC ELECTRONICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  1
  SUBSTANTIALLY EQUIVALENT 13
CURATRONIC, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 4
DOMINO S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
ELECTRONIC WAVEFORM LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELMED
  SUBSTANTIALLY EQUIVALENT 3
EMPI
  2
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  2
  SUBSTANTIALLY EQUIVALENT 4
FAMIDOC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 1
GENERAL PHYSIOTHERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
ITO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHARI DIGITAL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KINGLY STAR INTL. TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOALATY PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
METRON MEDICAL AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 5
METTLER ELECTRONICS CORP.
  3
  SUBSTANTIALLY EQUIVALENT 8
PHYSIOFIELD
  SUBSTANTIALLY EQUIVALENT 1
REHABILICARE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  1
  SUBSTANTIALLY EQUIVALENT 16
RUDOLF STORZ GMBH
  1
  SUBSTANTIALLY EQUIVALENT 7
SAN SHIH ELECTRICAL ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1
THOUGHT TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Charred 9
Temperature issue 9
No Known Device Problem 2
Unknown (for use when the device problem is not known) 1
No Information 1
Total Device Problems 22

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

Recalls
Manufacturer Recall Class Date Posted
1 International Rehabilitative Sciences, Inc. II Nov-08-2010
2 Ion Genius, Inc. II Mar-01-2012
3 Zynex Medical, Inc. II Jun-26-2014
4 eSwallow USA LLC II Jul-25-2011

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