Cleared Traditional

Brainsway Deep (DTMS) System

K203616 · Brainsway , Ltd. · Neurology
Apr 2021
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K203616 is an FDA 510(k) clearance for the Brainsway Deep (DTMS) System, a Transcranial Magnetic Stimulation System For Smoking Cessation (Class II — Special Controls, product code QMD), submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 16, 2021, 127 days after receiving the submission on December 10, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number K203616 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2020
Decision Date April 16, 2021
Days to Decision 127 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QMD — Transcranial Magnetic Stimulation System For Smoking Cessation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5802
Definition Intended For Use As A Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions.