Data / Medical devices / Israel / Brainsway Ltd.

Brainsway Ltd.: FDA-registered device maker in Jerusalem, Israel, 9 510(k) clearances

Name: Brainsway Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Brainsway Ltd. is registered with the FDA (registration 3010300912) in Jerusalem, Israel. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 26, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010300912
Address: 16 Hartom Str. Har Hahotzvim, Jerusalem, Israel, 9777516
Owner or operator: Brainsway Ltd. (10044527)
Roles: Manufacturer
First device listed: June 24, 2013
Registered through: 2026
Brand names listed: BrainsWay Deep TMS System for Smoking Cessation (Model 102), BrainsWay Deep TMS System for Smoking Cessation (Model 104), BrainsWay Deep TMS System for Treatment of Decreasing Anxiety Symptoms in MDD (Model 102 & 104), BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 102), BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 104), BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) using iTBS (Model 102 & 104), BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 102), BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 104) and more

Devices it lists

Device	Product code	Class	Role	Source
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	QCI	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulation System For Smoking Cessation	QMD	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 26, 2022	K220819	BrainsWay Deep TMS System	OBP	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
August 17, 2021	K210201	Deep Transcranial Magnetic Stimulation (DTMS) System	OBP	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
April 23, 2021	K203735	Brainsway Deep TMS System	OBP	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
April 16, 2021	K203616	Brainsway Deep (DTMS) System	QMD	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
August 21, 2020	K200957	Brainsway Deep TMS System	QMD	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
March 8, 2019	K183303	Brainsway Deep TMS System	QCI	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
August 17, 2018	DEN170078	Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System	QCI	Unknown	Brainways , Ltd.	accessdata.fda.gov
May 3, 2018	K173540	Brainsway Deep (DTMS) System	OBP	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov
January 7, 2013	K122288	BRAINSWAY DEEP TMS SYSTEM	OBP	Substantially Equivalent	Brainsway , Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.