Iasis Technologies · Class unclassified · Cleared Mar 13, 2026
| K-number | K252923 |
| Device name | IASIS i2 Relaxation Neurofeedback System |
| Applicant | Iasis Technologies |
| Product code | — |
| Device class | Class unclassified |
| Decision date | Mar 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The IASIS i2 Relaxation Neurofeedback System is a medical device combining a multi-channel EEG recording device with Windows-based software to provide relaxation and stress reduction through EEG biofeedback. It captures brainwave signals, analyzes them in real-time, and delivers visual or auditory feedback to help patients voluntarily control their physiological parameters.
The device features a 2-channel isolated physiological signal recorder with 24-bit A/D resolution, 250 Hz sampling rate, 5 kV electrical isolation, 100 MΩ input impedance, and operates via USB connection to a Windows laptop. It includes cloud-based and local operation modes with encrypted data storage and secure communication protocols, distinguishing it from predicate devices.
IEC 60601-1-2:2014+A1:2020 (medical electrical equipment safety), IEC 80601-2-26:2019 (electroencephalograph requirements), CISPR 11:2015+A1:2016+A2:2019 (EMC emissions), IEC 61000 series (electromagnetic immunity testing), CFR 47 Part 15 (radiated and conducted emissions), and FDA guidance on electromagnetic compatibility.
The subject device is substantially equivalent because it operates on the same biofeedback principle as predicates K945826 and K990538, capturing and analyzing EEG signals to provide neurofeedback for relaxation and stress reduction. Key technical specifications including sampling rate, filters, and isolation are equivalent; differences in power source, dimensions, and added cybersecurity features do not introduce new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov