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510(k) K140094

SPRINGTMS TOTAL MIGRAINE SYSTEM by Eneura Therapeutics, LLC — Product Code OKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2014
Date Received
January 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Device Class
Class II
Regulation Number
882.5808
Review Panel
NE
Submission Type

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.

Other clearances by Eneura Therapeutics, LLC

  • DEN130022 — NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (December 13, 2013)

Other clearances for product code OKP

  • K230358 — SAVI Dual (TM) Migraine Therapy (May 16, 2023)
  • K182976 — SpringTMS (February 25, 2019)
  • K162797 — SpringTMS (June 26, 2017)
  • K161663 — sTMS mini (August 23, 2016)
  • DEN130022 — NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (December 13, 2013)