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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
510(k) Number K231337
FOIA Releasable 510(k) K231337
Device Name EndeavorRx
Applicant
Akili Interactive Labs, Inc.
125 Broad St., 5th Floor
Boston,,  MA  02110
Applicant Contact Bhupinder Singh
Correspondent
Hogan Lovells US LLP
22 Boston Wharf Rd.
7th Floor
Boston,  MA  02210
Correspondent Contact Bhupinder Singh
Regulation Number882.5803
Classification Product Code
QFT  
Date Received05/08/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04897074
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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