EndeavorRx™
Basic Information
- Brand Name
- EndeavorRx™
- Primary DI
- 00850002639018
- Version / Model
- Treatment 1
- Catalog Number
- 50002063901
- Company Name
- AKILI INTERACTIVE LABS, INC.
- Labeler DUNS
- 078413778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-11
- Public Version
- 5
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- ed3ec8ef-a53a-4768-bffb-71206cef7717
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QFT | Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder | Obstetrics/Gynecology | 882.5803 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63031 | Mental health/function therapeutic software, screen-viewed | A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850002639018 | GS1 |
Customer Contacts
- Phone
- 1-844-254-5447
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200026 | 000 |