FDA Registration
Active
🇷🇺 Russian Federation
NEUROSOFT LTD
Reg #: 3006418479
·
FEI: 3006418479
·
Expires 2026
Products
16
Proprietary Names
30
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- NEUROSOFT LTD
- Registration Number
- 3006418479
- FEI Number
- 3006418479
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Voronin Street
- City
- Ivanovo Ivanovskaya Oblast'
- Country
- RU
Regulatory Submissions
- 510(k) Number
- K102610
Owner / Operator
- Firm Name
- Neurosoft LTD
- Operator Number
- 10035792
- Address
- 5 Voronin Street
- City
- Ivanovo
- State
- Ivanovskaya Oblast'
- Postal Code
- 153032
- Country
- RU
- Correspondent
- Mikhail U Durdin
US Agent
- Business Name
- TeleEMG, LLC
- Contact Name
- Joe F Jabre
- Address
- 7304 Beverly Blvd #357
- City
- Los Angeles
- State
- CA
- ZIP
- 90036
- Country
- US
- [email protected]
- Phone
- 617 8403253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2011-03-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2011-03-24 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2015-06-25 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2015-06-25 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2015-06-25 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2021-08-20 |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | Class 2 | Neurology | No | 2023-12-25 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2023-08-11 |
| Tympanometer, Exempt | PTP | Class 2 | Ear, Nose, Throat | No | 2023-01-27 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2017-07-19 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2021-05-28 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2021-05-28 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2021-05-28 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2023-01-27 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2017-07-19 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2017-07-19 |
Proprietary Names
Focus
Neuro-MEP-Micro
Neuron-Spectrum-3 with Neuron-Spectrum.NET software
Neuron-Spectrum-2 with Neuron-Spectrum.NET software
Neuron-Spectrum-4 with Neuron-Spectrum.NET software
Neuron-Spectrum-4/P with Neuron-Spectrum.NET software
Neuron-Spectrum-1 with Neuron-Spectrum.NET software
NoetherTech
MEGA-TMS
Neuro-MS
CloudTMS Edge for OCD
Neuro-MSX
Steadys-Step gait analysis and gait training system
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
aTymp
Neurosoft TMS
CloudTMS
Cloud TMS
Focus TMS
FocusTMS
Neuro-MS/D
Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
Neuro-IOM
Rivus
NEURO-AUDIO
CloudEKG
Poly-Spectrum-8/EX
Neuro-MS/D for OCD
CloudTMS for OCD
CloudTMS Edge
Establishment Types
Manufacture Medical Device