FDA.reportPublic FDA data

Head Side Pad, 3 Pack

Primary DI
10850005944383
Brand
Head Side Pad, 3 Pack
Company
NEURONETICS, INC.
Model
81-00848-000
Device description
Head Side Pad to be used with the NeuroStar Advanced Therapy System
Published
2023-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive DisorderNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN070003000
K212289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN070003000NEUROSTAR TMS SYSTEMNeuronetics2008-10-07OBP
K212289000NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.2022-05-06QCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005944383PrimaryGS10
00085000594438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000594438310850005944383
00085000594438000850005944380850005944380085000594438

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
134960348
Device count
3
Manufacturing date on label
true
No natural rubber latex
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
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
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

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.QCI2026-10-21
10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.OBP2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.QCI2026-10-21
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 LIMITEDQCI2026-08-25
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDOBP2026-08-25
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
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
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
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
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14