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Brainsway Deep TMS System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200957

by Brainsway , Ltd.

Identifiers

510(k) Number
K200957 FDA 510(k)
FDA Product Code
QMD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5802 FDA 510(k)
Regulation Number
882.5802 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Brainsway Deep TMS System is a Transcranial Magnetic Stimulation (TMS) device designed for noninvasive neurostimulation. It delivers focused magnetic pulses to targeted brain regions, primarily used for treating conditions such as treatment-resistant depression and obsessive-compulsive disorder (OCD).

This system is supplied as a reusable medical device and includes a high-performance stimulator, touchscreen interface, and cooling system. It is intended for use in clinical settings, adhering to FDA clearance under 510(k) classification (K200957) and regulatory standards for Class II devices. Sterility and maintenance protocols are manufacturer-specified for optimal performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BrainsWay Deep TMS - Innovative, Noninvasive Treatment, Discover BrainsWay Deep TMS™ Products, BrainsWay Deep TMS™:, BrainsWay Deep TMS Review (2026): Price, Specs, Verdict

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainsway , Ltd.

Sources (1)

  • FDA 510(k) K200957 24 fields · synced Sep 19, 2026