FDA.reportPublic FDA data

OCD MT Cap

Primary DI
10850005944680
Brand
OCD MT Cap
Company
NEURONETICS, INC.
Model
85-00397-000
Device description
The OCD MT Cap is used to aid in the OCD motor threshold (MT) determination process.
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231350000OCD MT Cap (85-00397-000)Neuronetics2023-06-08QCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005944680PackageGS110In Commercial Distribution
00850005944683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000594468010850005944680
00850005944683008500059446838500059446830850005944683

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
134960348
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00850005944164Wedge Cushion, Gray87-00022-1002024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
00850005944935NeuroStar HeadrestNEURONETICS, INC.QCI2025-12-15
05713484031440MagPro accessoriesTonica Elektronik A/SQCI2025-12-11
00850005944911NeuroStar HeadrestNEURONETICS, INC.QCI2025-12-09
00850005944850NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-06-24
00850005944867NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-06-24
00850005944874NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-06-24
00850005944829NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-08
00850005944836NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-08
00850005944812NeuroStar Advanced Therapy SystemNEURONETICS, INC.QCI2025-05-07
06430063200187Nexstim NBS SystemNexstim OyjQCI2025-04-01
05713484030214MagPro accessoriesTonica Elektronik A/SQCI2025-03-13
05713484030023MagPro accessoriesTonica Elektronik A/SQCI2025-03-12
05713484031426MagPro AccessoriesTonica Elektronik A/SQCI2025-03-12
04260526050101Apollo Light TMS Therapy SystemMAG & More GmbHQCI2024-08-21
00850005944638SenStar Treatment LinkNEURONETICS, INC.QCI2024-08-02
00850005944652SenStar Connect Treatment LinkNEURONETICS, INC.QCI2024-08-02
00850005944041Arm Support Cushion, GrayNEURONETICS, INC.QCI2024-02-02
00850005944164Wedge Cushion, GrayNEURONETICS, INC.QCI2024-02-02
00850005944171Head Cushion Insert Set, GrayNEURONETICS, INC.QCI2024-02-02
00850005944188Arm Support Cushion, BlueNEURONETICS, INC.QCI2024-02-02
00850005944416Wedge Cushion, BlueNEURONETICS, INC.QCI2024-02-02
00850005944492Head Cushion Insert Set, BlueNEURONETICS, INC.QCI2024-02-02
04650075335895CloudTMS Edge for OCDNEUROSOFT, OOOQCI2024-01-12