SCP · Class II · 21 CFR 882.5801

FDA Product Code SCP: Computerized Behavioral Therapy Device For Anxiety Disorders

Computerized Behavioral Therapy Device For Psychiatric Disorders

Leading manufacturers include Big Health, Inc..

1
Total
1
Cleared
267d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Computerized Behavioral Therapy Device For Anxiety Disorders Devices (Product Code SCP)

1 devices
1–1 of 1

About Product Code SCP - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SCP since 2024, with 1 receiving FDA clearance (average review time: 267 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SCP devices are reviewed by the Neurology panel. Browse all Neurology devices →