Cleared Traditional

Ultimate rTMS

K243460 · Brain Ultimate, Inc. · Neurology
Apr 2025
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K243460 is an FDA 510(k) clearance for the Ultimate rTMS, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), 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 882.5805.

Submission Details

510(k) Number K243460 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 OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition 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.