FDA.reportPublic FDA data

NeuroStar Head Support System, Domestic

Primary DI
00850005944775
Brand
NeuroStar Head Support System, Domestic
Company
NEURONETICS, INC.
Model
81-07836-000
Device description
The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes.
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161519000NeuroStar TMS Therapy SystemNeuronetics, Inc.2016-09-11OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005944775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005944775008500059447758500059447750850005944775

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.

Contacts#

Phone, Email table
PhoneEmail
877-600-7555CustomerSupport@neurostar.com

Regulatory Flags#

DUNS number
134960348
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005944935NeuroStar Headrest81-72026-00R2025-12-15
00850005944881NeuroStar Head Support System, Domestic81-07836-00U2025-12-09
00850005944898NeuroStar Head Support System, Domestic81-04836-00U2025-12-09
00850005944911NeuroStar Headrest81-72026-00U2025-12-09
00850005944928D-Tect MT Accessory81-00241-00U2025-12-09
00850005944843NeuroStar Advanced Therapy SystemVersion 3.X81-02315-00U2025-06-24
00850005944850NeuroStar Advanced Therapy SystemVersion 3.681-03315-00U2025-06-24
00850005944867NeuroStar Advanced Therapy SystemVersion 3.781-04315-00U2025-06-24
00850005944874NeuroStar Advanced Therapy SystemVersion 3.881-05315-00U2025-06-24
00850005944829NeuroStar Advanced Therapy SystemVersion 3.781-04315-00R2025-05-08
00850005944836NeuroStar Advanced Therapy SystemVersion 3.881-05315-00R2025-05-08
00850005944812NeuroStar Advanced Therapy SystemVersion 3.681-03315-00R2025-05-07
00869378000117NeuroStar TMS Therapy SystemNeuroStar 3.0 US81-02315-0002016-09-20
00850005944638SenStar Treatment Link81-70100-0002024-08-02
10850005944635SenStar Treatment Link81-70100-0002024-08-02
00850005944652SenStar Connect Treatment Link81-71100-1002024-08-02
00850005944225SenStar Treatment Link81-70000-0002022-10-05
00850005944041Arm Support Cushion, Gray87-00021-1002024-02-02
00850005944164Wedge Cushion, Gray87-00022-1002024-02-02
00850005944171Head Cushion Insert Set, Gray87-00657-1002024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
04650075333273CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
04650075337783CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
00850005944935NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-15
05713484020482MagProTonica Elektronik A/SOBP2025-12-11
05713484031181MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031440MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031648MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
00850005944881NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944898NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944911NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-09
00850005944928D-Tect MT AccessoryNEURONETICS, INC.OBP2025-12-09
06430063200194Nexstim NBS White Head TrackerNexstim OyjOBP2025-10-17
06430063200200Nexstim Head Tracker TapeNexstim OyjOBP2025-10-17
00860012355419NQ TMS Applicator ArmNeuroqore, Inc.OBP2025-08-06