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510(k) K161663

sTMS mini by Eneura, Inc. — Product Code OKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2016
Date Received
June 16, 2016
Clearance Type
Special
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, Inc.

  • K230358 — SAVI Dual (TM) Migraine Therapy (May 16, 2023)
  • K162797 — SpringTMS (June 26, 2017)

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)
  • K140094 — SPRINGTMS TOTAL MIGRAINE SYSTEM (May 21, 2014)
  • DEN130022 — NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR (December 13, 2013)