510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SAPClass II

Computerized Behavioral Therapy Device For Depressive Disorders.

21 CFR 882.5801 / Neurology
FDA source (opens on fda.gov)

SAP is the FDA product code for Computerized Behavioral Therapy Device For Depressive Disorders., a class II device type, regulated under 21 CFR 882.5801. FDA's definition for this code reads: "The device is intended to provide computerized behavioral therapy to treat depressive disorders". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAP
Device name
Computerized Behavioral Therapy Device For Depressive Disorders.
FDA definition
The device is intended to provide computerized behavioral therapy to treat depressive disorders.
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code SAP

By decision year
3 clearances under product code SAP with a decision year between 2024 and 2026, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SAP by decision year
YearClearances
20242
20261

Applicants with the most clearances

Product code SAP
Applicants holding the most 510(k) clearances under product code SAP
ApplicantClearances
Click Therapeutics, Inc.1
Curio Digital Therapeutics1
Otsuka America Pharmaceutical, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code