Cleared Traditional

Brainsway Deep TMS System

K200957 · Brainsway , Ltd. · Neurology
Aug 2020
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K200957 is an FDA 510(k) clearance for the Brainsway Deep TMS 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 August 21, 2020, 134 days after receiving the submission on April 9, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number K200957 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2020
Decision Date August 21, 2020
Days to Decision 134 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.