K231209 is an FDA 510(k) clearance for the Rejoyn. This device is classified as a Computerized Behavioral Therapy Device For Depressive Disorders. (Class II - Special Controls, product code SAP).
Submitted by Otsuka America Pharmaceutical, Inc. (Rockville, US). The FDA issued a Cleared decision on March 30, 2024, 338 days after receiving the submission on April 27, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5801. The Device Is Intended To Provide Computerized Behavioral Therapy To Treat Depressive Disorders..
| 510(k) Number | K231209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2023 |
| Decision Date | March 30, 2024 |
| Days to Decision | 338 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | SAP - Computerized Behavioral Therapy Device For Depressive Disorders. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5801 |
| Definition | The Device Is Intended To Provide Computerized Behavioral Therapy To Treat Depressive Disorders. |