Data / Medical devices / Russia / Neurosoft Ltd

Neurosoft Ltd: FDA-registered device maker in Ivanovo Ivanovskaya Oblast', Russia, 12 510(k) clearances

Name: Neurosoft Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neurosoft Ltd is registered with the FDA (registration 3006418479) in Ivanovo Ivanovskaya Oblast', Russia. It lists 16 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 14, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006418479
Address: 5 Voronin Street, Ivanovo Ivanovskaya Oblast', Russia, 153009
Owner or operator: Neurosoft LTD (10035792)
Roles: Manufacturer
First device listed: March 24, 2011
Registered through: 2026
Brand names listed: Cloud TMS, CloudEKG, CloudTMS, CloudTMS Edge, CloudTMS Edge for OCD, CloudTMS for OCD, Focus, Focus TMS and more

Devices it lists

Device	Product code	Class	Role	Source
Audiometer	EWO	2	Manufacturer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	QCI	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Manufacturer	accessdata.fda.gov
Tympanometer, Exempt	PTP	2	Manufacturer	accessdata.fda.gov
Uroflowmeter	EXY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2025	K250689	CloudTMS Edge	OBP	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
December 22, 2023	K233742	CloudTMS Edge for OCD	QCI	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
March 10, 2023	K221129	CloudTMS for OCD	QCI	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
November 30, 2022	K220254	Neuron-Spectrum-AM with Neuron-Spectrum.NET Software	OLT	Substantially Equivalent	Neurosoft , Ltd.	accessdata.fda.gov
August 13, 2021	K192823	MEGA-TMS	GWF	Substantially Equivalent	Soterix Medical, Inc.	accessdata.fda.gov
May 22, 2021	K190703	Neuro-IOM system with Neuro-IOM.NET software	GWF	Substantially Equivalent	Neurosoft , Ltd.	accessdata.fda.gov
December 13, 2017	K173441	Neurosoft TMS (also CloudTMS)	OBP	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
December 22, 2016	K160309	Neurosoft TMS	OBP	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
June 19, 2015	K133995	NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE	OLT	Substantially Equivalent	Neurosoft , Ltd.	accessdata.fda.gov
March 12, 2015	K141524	NEURO-AUDIO	EWO	Substantially Equivalent	Teleemg, LLC USA	accessdata.fda.gov
April 4, 2014	K130878	CLOUDEKG	DXH	Substantially Equivalent	Makromed, Inc.	accessdata.fda.gov
March 4, 2011	K102610	FOCUS EMG DEVICE	IKN	Substantially Equivalent	Teleemg, LLC USA	accessdata.fda.gov

Compare with other makers

Updated September 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.