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.
- 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.