DEN200026 is an FDA 510(k) submission for the EndeavorRx. This device is classified as a Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder (Class II - Special Controls, product code QFT).
Submitted by Akili Interactive Labs, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on June 15, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5803. 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..
| 510(k) Number | DEN200026 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 16, 2020 |
| Decision Date | June 15, 2020 |
| Days to Decision | 60 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QFT - Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5803 |
| Definition | 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. |