SAP
- Product code
- SAP
- Device name
- Computerized Behavioral Therapy Device For Depressive Disorders.
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5801
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
FDA classification definition
The device is intended to provide computerized behavioral therapy to treat depressive disorders.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254038 | 2026-07-30 | Click Therapeutics, Inc. | Motivista (CT-155) | |
| K223515 | 2024-04-22 | Curio Digital Therapeutics, Inc. | MamaLift Plus | |
| K231209 | 2024-03-30 | Otsuka America Pharmaceutical, Inc. | Rejoyn |
Official FDA classification page: SAP
Classification and pathway per current FDA publications. Data from openFDA (CC0).