QWI · Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Neurology · 21 CFR 882.5804 · Class 2
Overview
| Product Code | QWI |
|---|---|
| Device Name | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms |
| Regulation | 21 CFR 882.5804 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription only device intended to provide a computerized version of a behavioral therapy for the treatment of fibromyalgia symptoms. Stanza is a prescription digital therapeutic that provides Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy, and is indicated for the treatment of fibromyalgia symptoms in adult patients.
Classification Rationale
Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the computerized behavioral therapy device for treatment of fibromyalgia symptoms is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220083 | Stanza | Swing Therapeutics, Inc. | May 9, 2023 | DENG |
Top Applicants
- Swing Therapeutics, Inc. — 1 clearance
