CloudTMS Edge for OCD

Q: What is the product code of K233742?

The FDA product code is QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5802.

FDA 510(k) K233742 · Teleemg, LLC

Substantially Equivalent

510(k) numberK233742

Submission

Device name: CloudTMS Edge for OCD
Applicant: Teleemg, LLC
Los Angeles, CA, US
Received: November 22, 2023
Decision date: December 22, 2023
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5802
Specialty: Neurology

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 510(k)s with product code QCI

510(k)	Device	Applicant	Decision
K243459	Ultimate rTMS for OCD (M-series)QCI · Traditional	Brain Ultimate, Inc.	04/17/2025SE
K230657	BTL-99-OCQCI · Traditional	BTL Industries, Inc.	02/01/2024SE
K231350	OCD MT Cap (85-00397-000)QCI · Special	Neuronetics	06/08/2023SE
K221129	CloudTMS for OCDQCI · Traditional	Teleemg, LLC	03/10/2023SE
K212289	NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…QCI · Traditional	Neuronetics, Inc.	05/06/2022SE
K193006	MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy systemQCI · Traditional	Tonica Elektronik A/S	08/09/2020SE
K183303	Brainsway Deep TMS SystemQCI · Traditional	Brainsway , Ltd.	03/08/2019SE

More from Brainsway , Ltd.

510(k)	Device	Decision
K250689	CloudTMS EdgeOBP · Traditional	09/14/2025SE
K221129	CloudTMS for OCDQCI · Traditional	03/10/2023SE
K173441	Neurosoft TMS (also CloudTMS)OBP · Special	12/13/2017SE
K160309	Neurosoft TMSOBP · Traditional	12/22/2016SE

Questions and answers

When was CloudTMS Edge for OCD cleared by the FDA?

CloudTMS Edge for OCD (K233742) received a 510(k) decision of Substantially Equivalent on December 22, 2023, 30 days after the submission was received.

What is the product code of K233742?

The FDA product code is QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5802.