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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
Regulation Description Transcranial magnetic stimulator for 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

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Muscle Weakness/Atrophy 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Numbness 1 1
Ambulation or Postural Difficulties 1 1
Fall 1 1
Headache 1 1
Tinnitus 1 1

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