FDA.reportPublic FDA data

CloudTMS Edge for OCD

Primary DI
04650075335949
Brand
CloudTMS Edge for OCD
Company
NEUROSOFT, OOO
Model
Irbis cooling unit
Device description
No description
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K233742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233742000CloudTMS Edge for OCDTeleemg, LLC2023-12-22QCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04650075335949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075335949046500753359494650075335949

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
617 8403253Jjabre@teleemg.com

Regulatory Flags#

DUNS number
643212926
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04650075333273CloudTMS EdgeCooling unit2026-01-23
04650075337783CloudTMS EdgeMain unit2026-01-23
04650075336922RivusRivus2024-12-20
04650075339992RivusRivus2023-02-02
04650075335895CloudTMS Edge for OCDMain unit2024-01-12
04650075335932CoudTMS Edge for OCDExtra power supply unit2024-01-12
04650075333792CloudTMS for OCDMain unit2023-12-14
04650075333952CloudTMS for OCDCooling unit2023-12-14
04650075333969CloudTMS for OCDExtra power supply unit2023-12-14
04650075330036Neuro-AudioNeuro-Audio2016-09-22
04650075332078Steadys-StepSteadys-Step2023-08-14
04650075330081CloudEKGCloudEKG2016-09-21
04650075330296CloudTMSCloudTMS2017-12-21
04650075334003aTympaTymp2023-02-02
04650075331392Neuron-Spectrum-AMNeuron-Spectrum-AM2022-12-19
04650075333211Neuron-SpectrumCloudEEG2021-07-22
04650075330074FocusFocus2016-09-22
04650075330098Neuron-SpectrumNeuron-Spectrum-12016-09-22
04650075330104Neuron-SpectrumNeuron-Spectrum-22016-09-22
04650075330111Neuron-SpectrumNeuron-Spectrum-32016-09-22

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