BRAINSWAY LTD.

FDA Device Registration & Listing · Jerusalem, IL · Registration 3010300912

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010300912
FEI Number
3010300912
Entity Name
BRAINSWAY LTD.
City/State/Country
Jerusalem, IL
Establishment Address
16 Hartom Str., Har Hahotzvim, Jerusalem 9777516, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Brainsway Ltd. (Owner Number: 10044527)
Owner / Operator Contact Address
16 Hartom Str., Har Hahotzvim, Jerusalem, IL-JM 9777516, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220819
PMA Number
N/A

All Registered Proprietary Names

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 104) BrainsWay Deep TMS System for Smoking Cessation (Model 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 Obsessive Compulsive Disorder (OCD) (Model 102) BrainsWay Deep TMS system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2021-11-14
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2020-08-13
QMD Transcranial Magnetic Stimulation System For Smoking Cessation Neurology Class 2 882.5802 2021-11-14
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2013-06-24
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2020-08-13
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2020-08-13
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2025-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

Naphtali Deutsch Email: ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

Brainsway Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243700 Mag & More GmbH Apollo TMS Therapy System 2025-09-04
K231926 Neuronetics, Inc. NeuroStar Advanced Therapy System (All previously cleared models) 2024-03-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010300912. Last updated year: 2026. Please use registration number 3010300912 when referencing this establishment in official correspondence.
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