Atlas FDA

SAP

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Computerized Behavioral Therapy Device For Depressive Disorders.
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5801
Medical specialty
Neurology
FDA definition
The device is intended to provide computerized behavioral therapy to treat depressive disorders.
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RecordFirmDate
Motivista (CT-155) (K254038)Click Therapeutics, Inc.2026-07-30
MamaLift Plus (K223515)Curio Digital Therapeutics, Inc.2024-04-22
Rejoyn (K231209)Otsuka America Pharmaceutical, Inc.2024-03-30

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Every clearance here is in the API, with alerts when new ones post.