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

Computerized Behavioral Therapy Device For Anxiety Disorders

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

SCP is the FDA product code for Computerized Behavioral Therapy Device For Anxiety Disorders, a class II device type, regulated under 21 CFR 882.5801. FDA's definition for this code reads: "Computerized behavioral therapy device for psychiatric disorders". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SCP
Device name
Computerized Behavioral Therapy Device For Anxiety Disorders
FDA definition
Computerized behavioral therapy device for psychiatric 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
1
Ingested recalls
0

Clearances, product code SCP

By decision year
1 clearance under product code SCP with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SCP by decision year
YearClearances
20241

Applicants with the most clearances

Product code SCP
Applicants holding the most 510(k) clearances under product code SCP
ApplicantClearances
Big Health Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code