Home / Device Classification / SAP

SAP — Computerized Behavioral Therapy Device For Depressive Disorders. Class II

FDA Device Classification

Classification Details

Product Code
SAP
Device Class
Class II
Regulation Number
882.5801
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

The device is intended to provide computerized behavioral therapy to treat depressive disorders.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223515curio digital therapeuticsMamaLift PlusApril 22, 2024
K231209otsuka america pharmaceuticalRejoynMarch 30, 2024