QWI · Class II · 21 CFR 882.5804

FDA Product Code QWI: Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Provides Acceptance And Commitment Therapy (act), A Form Of Cognitive Behavioral Therapy (cbt), For Patients With Fibromyalgia Symptoms

Leading manufacturers include Swing Therapeutics, Inc..

1
Total
0
Cleared
169d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms Devices (Product Code QWI)

1 devices
1–1 of 1

About Product Code QWI - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWI since 2023, with 0 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

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