Cleared Traditional

BrainsWay Deep TMS System

K251449 · Brainsway , Ltd. · Neurology
Sep 2025
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K251449 is an FDA 510(k) clearance for the BrainsWay Deep TMS System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on September 13, 2025, 127 days after receiving the submission on May 9, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K251449 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date September 13, 2025
Days to Decision 127 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.