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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcranial magnetic stimulator for the treatment of migraine headache
Definition Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.
Product CodeOKP
Regulation Number 882.5808
Device Class 2


Premarket Reviews
ManufacturerDecision
ENEURA INC
  SUBSTANTIALLY EQUIVALENT 1
ENEURA INC.
  SUBSTANTIALLY EQUIVALENT 1
ENEURA THERAPEUTICS
  GRANTED 1
ENEURA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENEURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENEURA® INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Therapeutic Results 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 2 2
Anxiety 2 2
Ambulation Difficulties 2 2
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
No Code Available 1 1
Neurological Deficit/Dysfunction 1 1
Therapeutic Effects, Unexpected 1 1
Tingling 1 1
Foreign Body Sensation in Eye 1 1

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