FDA.reportPublic FDA data

CloudTMS Edge for OCD

Primary DI
04650075335895
Brand
CloudTMS Edge for OCD
Company
NEUROSOFT, OOO
Model
Main unit
Device description
The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
04650075335895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075335895046500753358954650075335895

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
04650075335932CoudTMS Edge for OCDExtra power supply unit2024-01-12
04650075335949CloudTMS Edge for OCDIrbis cooling 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
04650075335932CoudTMS Edge for OCDNEUROSOFT, OOOQCI2024-01-12