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FDA 510(k)

IASIS i2 Relaxation Neurofeedback System

K-Number: K252923 · 2026-03-13

ApplicantIasis Technologies
Decision Date2026-03-13
Product Code
DecisionSubstantially Equivalent

Device Summary

IASIS i2 Relaxation Neurofeedback System is a medical device manufactured by Iasis Technologies. It received FDA 510(k) clearance on 2026-03-13 under approval number K252923. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IASIS i2 Relaxation Neurofeedback System?

IASIS i2 Relaxation Neurofeedback System is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Iasis Technologies. The 510(k) number is K252923.

When was IASIS i2 Relaxation Neurofeedback System approved by the FDA?

IASIS i2 Relaxation Neurofeedback System received FDA 510(k) clearance on 2026-03-13, under approval number K252923.

What company makes IASIS i2 Relaxation Neurofeedback System?

IASIS i2 Relaxation Neurofeedback System is manufactured by Iasis Technologies.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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