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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K252923
Device Name IASIS i2 Relaxation Neurofeedback System
Applicant
Iasis Technologies
38975 Sky Canyon Dr. #105
Murrieta,  CA  92563
Applicant Contact Larry Wedekind
Correspondent
Mdi Consultants, Inc.
55 Northen Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Rajal
Date Received09/15/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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