FDA.reportPublic FDA data

Deep Transcranial Magnetic Stimulation (DTMS) System

Primary DI
07290110537142
Brand
Deep Transcranial Magnetic Stimulation (DTMS) System
Company
BRAINSWAY LTD
Model
102/102B
Device description
102 Deep TMS system with H4 coil
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QMDTranscranial Magnetic Stimulation System For Smoking Cessation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMDTranscranial Magnetic Stimulation System For Smoking CessationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200957000Brainsway Deep TMS SystemBrainsway , Ltd.2020-08-21QMD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110537142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110537142072901105371427290110537142

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.

Regulatory Flags#

DUNS number
531873441
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) System1022026-05-07
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) System102/102B2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-001-R2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-002-R2026-05-07
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-01200D-CPLX2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-07200D-CPLX2026-03-14
07290110530204Deep Transcranial Magnetic Stimulation (DTMS) System104HEL-04000D-CPLX2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000011-KIT2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000012-KIT2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000013-KIT2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) System104CAP-000014-KIT2026-03-14
07290110537197Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3042026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3012026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0012026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0022026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0302026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0312026-03-14
07290110538125Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0072026-03-14
07290110538132Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-0332026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) System104SYS-104-3072026-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110530204Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQMD2026-03-14
07290110537197Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQMD2026-03-14
07290110538125Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQMD2026-03-14
07290110538132Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQMD2026-03-14