K231337 is an FDA 510(k) clearance 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 Cleared decision on December 13, 2023, 219 days after receiving the submission on May 8, 2023.
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 | K231337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |