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510(k) K233742

CloudTMS Edge for OCD by Teleemg, LLC — Product Code QCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
November 22, 2023
Clearance Type
Special
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 Teleemg, LLC

  • K250689 — CloudTMS Edge (September 14, 2025)
  • K221129 — CloudTMS for OCD (March 10, 2023)
  • K173441 — Neurosoft TMS (also CloudTMS) (December 13, 2017)
  • K160309 — Neurosoft TMS (December 22, 2016)

Other clearances for product code QCI

  • K243459 — Ultimate rTMS for OCD (M-series) (April 17, 2025)
  • K230657 — BTL-99-OC (February 1, 2024)
  • 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)