Cleared Traditional

Deep TMS System

K222196 · Brainsway , Ltd. · Neurology
May 2024
Decision
679d
Days
Class 2
Risk

About This 510(k) Submission

K222196 is an FDA 510(k) clearance for the 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 May 31, 2024, 679 days after receiving the submission on July 22, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K222196 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2022
Decision Date May 31, 2024
Days to Decision 679 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.