CloudTMS Edge

FDA 510(k) K250689 · Teleemg, LLC

Substantially Equivalent

510(k) numberK250689

Submission

Device name
CloudTMS Edge
Applicant
Teleemg, LLC
Los Angeles, CA, US
Received
March 6, 2025
Decision date
September 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBP – Transcranial Magnetic Stimulator
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5805
Specialty
Neurology

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 510(k)s with product code OBP

510(k)DeviceApplicantDecision
K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional Fidelity BioPharma Co.09/06/2026SE
K260691BTL-699OBP · Traditional BTL Industries, Inc.08/23/2026SE
K261228QuickVision Ultimate rTMSOBP · Traditional Brain Ultimate, Inc.08/14/2026SE
K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional Mag & More GmbH05/22/2026SE
K260189MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional Tonica Elektronik A/S05/22/2026SE
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional Nexstim Oyj03/20/2026SE
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional Nexstim Oyj03/20/2026SE
K251653SPRY TMS Therapy System (0550)OBP · Traditional Soterix Medical, Inc.02/20/2026SE
K251391BrainsWay Deep TMS SystemOBP · Traditional Brainsway , Ltd.11/07/2025SE
K251449BrainsWay Deep TMS SystemOBP · Traditional Brainsway , Ltd.09/13/2025SE

More from Brainsway , Ltd.

510(k)DeviceDecision
K233742CloudTMS Edge for OCDQCI · Special 12/22/2023SE
K221129CloudTMS for OCDQCI · Traditional 03/10/2023SE
K173441Neurosoft TMS (also CloudTMS)OBP · Special 12/13/2017SE
K160309Neurosoft TMSOBP · Traditional 12/22/2016SE

Questions and answers

When was CloudTMS Edge cleared by the FDA?

CloudTMS Edge (K250689) received a 510(k) decision of Substantially Equivalent on September 14, 2025, 192 days after the submission was received.

What is the product code of K250689?

The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.