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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interferential current therapy
Product CodeLIH
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAN NEUROMEDICAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTAFLEX INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJI DYNAMICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GEMORE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THERASIGMA, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION QUEST INDUSTRIES INC./ DBA VQ ORTHOCARE
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 1 1
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Temperature Problem 1 1
Unintended Power Up 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 2 2
Burn(s) 1 1
Edema 1 1
Erythema 1 1
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Pain 1 1
Shock 1 1
Discomfort 1 1
Alteration In Body Temperature 1 1

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