Cleared Traditional

Deep Transcranial Magnetic Stimulation (DTMS) System

K210201 · Brainsway , Ltd. · Neurology
Aug 2021
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K210201 is an FDA 510(k) clearance for the Deep Transcranial Magnetic Stimulation (DTMS) 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 August 17, 2021, 204 days after receiving the submission on January 25, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K210201 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date August 17, 2021
Days to Decision 204 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.