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510(k) K250689

CloudTMS Edge by Teleemg, LLC — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2025
Date Received
March 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

Other clearances by Teleemg, LLC

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  • 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 OBP

  • K251653 — SPRY TMS Therapy System (0550) (February 20, 2026)
  • K251391 — BrainsWay Deep TMS System (November 7, 2025)
  • K251449 — BrainsWay Deep TMS System (September 13, 2025)
  • K243700 — Apollo TMS Therapy System (September 4, 2025)
  • K243539 — Apollo TMS Therapy System (August 18, 2025)
  • K251125 — MagVenture TMS Therapy System (August 11, 2025)
  • K251119 — MagVenture TMS Therapy System (August 8, 2025)
  • K252032 — T65 (9016E061-) (July 30, 2025)
  • K251210 — Ampa One System (AMPA-001) (June 27, 2025)
  • K243460 — Ultimate rTMS (April 17, 2025)