510(k) K233496
K233496 is an FDA 510(k) premarket notification submitted by Akili Interactive Labs, Inc. for the device "EndeavorOTC". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code QFT (Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder), a Class II device regulated under 21 CFR 882.5803. Akili Interactive Labs, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2024
- Date Received
- October 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
- Device Class
- Class II
- Regulation Number
- 882.5803
- Review Panel
- NE
- Submission Type
A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.