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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 stimulator, transcutaneous electrical, aesthetic purposes
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Product CodeNFO
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
BENTLEY BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CAROL COLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO CURRENT TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUTRA LUXE MD, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRETIKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAMA RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TROPHY SKIN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 2
Leak / Splash 1
Insufficient Information 1
Total Device Problems 4


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