21 CFR 882.5804 — Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5804
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWI | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms | 2 | 1 |
Special Controls
QWI — Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
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:
De Novo Order DEN220083
