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510(k) K243459

Ultimate rTMS for OCD (M-series) by Brain Ultimate, Inc. — Product Code QCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

Other clearances by Brain Ultimate, Inc.

  • K243460 — Ultimate rTMS (April 17, 2025)
  • K230735 — Ultimate rTMS; Yingchi rTMS (September 13, 2023)

Other clearances for product code QCI

  • K230657 — BTL-99-OC (February 1, 2024)
  • K233742 — CloudTMS Edge for OCD (December 22, 2023)
  • K231350 — OCD MT Cap (85-00397-000) (June 8, 2023)
  • K221129 — CloudTMS for OCD (March 10, 2023)
  • K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced T (May 6, 2022)
  • K193006 — MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
  • K183303 — Brainsway Deep TMS System (March 8, 2019)
  • DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2018)