IASIS i2 Relaxation Neurofeedback System— 510(k) K252923
Substantially EquivalentIasis Technologies
FDA 510(k) clearance K252923 for IASIS i2 Relaxation Neurofeedback System, Substantially Equivalent on 2026-03-13. Applicant: Iasis Technologies.
Summary
Iasis Technologies' IASIS i2 Relaxation Neurofeedback System has no product code, device class, or regulation number in this record. The record doesn't describe the system beyond its name.
The classification panel is listed as Unknown, and the Neurology review panel handled it as a Traditional 510(k).
Iasis Technologies filed from Murrieta, California. The decision came 179 calendar days after FDA received it (September 15, 2025 to March 13, 2026).
Clearance details
- Applicant
- Iasis Technologies
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrieta, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.