FDA.reportPublic FDA data

CloudTMS Edge

Primary DI
04650075337783
Brand
CloudTMS Edge
Company
NEUROSOFT, OOO
Model
Main unit
Device description
The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
Published
2026-01-23
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
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250689000CloudTMS EdgeTeleemg, LLC2025-09-14OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04650075337783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075337783046500753377834650075337783

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 8403263Jjabre@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
04650075336922RivusRivus2024-12-20
04650075339992RivusRivus2023-02-02
04650075335895CloudTMS Edge for OCDMain unit2024-01-12
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
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
00850005944935NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-15
05713484020482MagProTonica Elektronik A/SOBP2025-12-11
05713484031181MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031440MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031648MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
00850005944881NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944898NeuroStar Head Support System, DomesticNEURONETICS, INC.OBP2025-12-09
00850005944911NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-09
00850005944928D-Tect MT AccessoryNEURONETICS, INC.OBP2025-12-09
06430063200194Nexstim NBS White Head TrackerNexstim OyjOBP2025-10-17
06430063200200Nexstim Head Tracker TapeNexstim OyjOBP2025-10-17
00860012355419NQ TMS Applicator ArmNeuroqore, Inc.OBP2025-08-06
00860012355426NQ TMS ApplicatorNeuroqore, Inc.OBP2025-08-06