EndeavorRx™ 50002063901
GUDID 00850002639018
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. The EndeavorRx program is software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home. EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili’s proprietary, patented, technology platform which is designed for the selective targeting and modulation of specific cognitive neural systems in the brain related to attention function. EndeavorRx uses Akili’s adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver the presentation of stimuli that are designed to engage targeted neural systems which play a key role in attention function. In a closed-loop system, the adaptive SSME algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient. EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.
AKILI INTERACTIVE LABS, INC.
Cognitive therapy software| Primary Device ID | 00850002639018 |
| NIH Device Record Key | ed3ec8ef-a53a-4768-bffb-71206cef7717 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndeavorRx™ |
| Version Model Number | Treatment 1 |
| Catalog Number | 50002063901 |
| Company DUNS | 078413778 |
| Company Name | AKILI INTERACTIVE LABS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002639018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN200026
FDA Product Code
| QFT | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-11 |
Trademark Results [EndeavorRx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDEAVORRX 90069243 not registered Live/Pending |
Akili Interactive Labs, Inc. 2020-07-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.