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 fda.gov
| 2-Channel Portable EMG, NCS and EP System Focus |
Focus brochure US website |
Approval letter k102610 |
| Transcranial Magnetic Stimulator CloudTMS |
CloudTMS website |
Approval letters k173441 k160309 k221129 |
| Transcranial Magnetic Stimulator MEGA-TMS |
Soterix website |
Approval letter k192823 |
| 12-channel Miniature Wireless ECG System CloudEKG |
CloudEKG brochure |
Approval letter k130878 |
| Clinical ABR&OAE Analyzer, Screening Audiometer Neuro-Audio |
Neuro-Audio brochure |
Approval letter k141524 |
| Digital EEG System Series Neuron-Spectrum-1, 2, 3, 4, 4/P |
Neuron-Spectrum brochure |
Approval letter k133995 |
| Multimodal System for Intraoperative Neurophysiologic Monitoring Neuro-IOM System |
Neuro-IOM System brochure |
Approval letter k190703 |
| 21-channel ambulatory EEG recorder Neuron-Spectrum-AM |
Neuron-Spectrum-AM brochure |
Approval letter K220254 |
| Gait Assessment and Training System with Biofeedback Steadys-Step |
Steadys-Step brochure |
Listing number D510366 |
| Uroflowmeter Rivus | Rivus brochure |
Listing number D494777 |
| Tympanometer aTymp | aTymp brochure |
Listing number D494783 |
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.