For US customers

  • In the US, FDA clearance is required prior to the sales and marketing of medical devices.
  • Neurosoft medical devices listed below are cleared by the FDA.
  • All questions regarding the FDA clearance of Neurosoft medical devices, IDE and IRB should be directed to reeny[@]neurosoft[.]com, engineer of Neurosoft’s Quality Assurance and Regulatory Affairs department.
  • For more information, you may also consult the FDA website
US Customers
2-Channel Portable EMG, NCS
and EP System Focus
Focus brochure
US website
Approval letter
Transcranial Magnetic
Stimulator CloudTMS
CloudTMS website Approval letters
Transcranial Magnetic
Stimulator MEGA-TMS
Soterix website Approval letter
12-channel Miniature Wireless
ECG System CloudEKG
CloudEKG brochure Approval letter
Clinical ABR&OAE Analyzer,
Screening Audiometer Neuro-Audio
Neuro-Audio brochure Approval letter
Digital EEG System Series
Neuron-Spectrum-1, 2, 3, 4, 4/P
Neuron-Spectrum brochure Approval letter
Multimodal System for Intraoperative
Neurophysiologic Monitoring Neuro-IOM System
Neuro-IOM System brochure Approval letter
Uroflowmeter Rivus Rivus brochure Listing number
Tympanometer aTymp aTymp brochure Listing number

Uses other than listed in the Device’s Intended Use as outlined in the 510(k) summary have not been cleared by the FDA and should be considered for Investigational Use only.

Products manufactured by Neurosoft that have not been cleared by the FDA are considered Investigational Devices and are subject to Investigational Device Exemption (IDE) and Institutional Review Board (IRB) review before their use.

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