K223515 is an FDA 510(k) clearance for the MamaLift Plus. This device is classified as a Computerized Behavioral Therapy Device For Depressive Disorders. (Class II - Special Controls, product code SAP).
Submitted by Curio Digital Therapeutics, Inc. (Princeton, US). The FDA issued a Cleared decision on April 22, 2024, 517 days after receiving the submission on November 22, 2022.
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 | K223515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2022 |
| Decision Date | April 22, 2024 |
| Days to Decision | 517 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. |