510(k) K223515
K223515 is an FDA 510(k) premarket notification submitted by Curio Digital Therapeutics, Inc. for the device "MamaLift Plus". The FDA issued a decision of Substantially Equivalent on April 22, 2024. The device falls under product code SAP (Computerized Behavioral Therapy Device For Depressive Disorders.), a Class II device regulated under 21 CFR 882.5801.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2024
- Date Received
- November 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Behavioral Therapy Device For Depressive Disorders.
- Device Class
- Class II
- Regulation Number
- 882.5801
- Review Panel
- NE
- Submission Type
The device is intended to provide computerized behavioral therapy to treat depressive disorders.