FDA.reportPublic FDA data

NeuroStar Advanced Therapy System

Primary DI
00850005944843
Brand
NeuroStar Advanced Therapy System
Company
NEURONETICS, INC.
Model
Version 3.X
Catalog number
81-02315-00U
Device description
NeuroStar Advanced Therapy System, Demo
Published
2025-06-24
Public version status
Update
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
00850005944843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005944843008500059448438500059448430850005944843

Sterilization Methods#

Method table
Method

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
10850005944963Hygiene Barrier, 50 Pack81-72045-0002026-10-21
10850005944970Strap, Head Positioning81-05336-0002026-10-21
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
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
00850005944775NeuroStar Head Support System, Domestic81-07836-0002025-06-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713484030245MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
05713484031754MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.OBP2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.OBP2026-10-21
G792699APM21MUS00EXOMIND applicatorBTL INDUSTRIES FZEOBP2026-10-09
G792699HEADREST1MUS00HeadrestBTL INDUSTRIES FZEOBP2026-10-09
G792699PO2M21MUS00EXOMINDBTL INDUSTRIES FZEOBP2026-10-09
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDOBP2026-08-25
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
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