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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device distal transcutaneous electrical stimulator for treatment of acute migraine
Definition A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
Product CodeQGT
Regulation Number 882.5899
Device Class 2


Premarket Reviews
ManufacturerDecision
THERANICA BIO-ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
THERANICA BIOELECTRONICS LTD
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nausea 1 1
Tinnitus 1 1
Electric Shock 1 1
Balance Problems 1 1
Spontaneous Abortion 1 1
Insufficient Information 1 1

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