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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Behavioral Therapy Device For Depressive Disorders.
510(k) Number K254038
Device Name Motivista (CT-155)
Applicant
Click Therapeutics, Inc.
80 White St., 3rd Floor
New York,  NY  10013
Applicant Contact Austin Speier
Correspondent
Click Therapeutics, Inc.
80 White St.
3rd Floor
New York,  NY  10013
Correspondent Contact Austin Speier
Regulation Number882.5801
Classification Product Code
SAP  
Date Received12/16/2025
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT05838625
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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