Cleared Traditional

Ultimate rTMS for OCD (M-series)

K243459 · Brain Ultimate, Inc. · Neurology

Apr 2025

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K243459 is an FDA 510(k) clearance for the Ultimate rTMS for OCD (M-series), a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by Brain Ultimate, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 17, 2025, 160 days after receiving the submission on November 8, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K243459 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2024
Decision Date	April 17, 2025
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	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).