Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5804](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5804) → QWI — Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

# QWI · Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

_Neurology · 21 CFR 882.5804 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QWI

## Overview

- **Product Code:** QWI
- **Device Name:** Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
- **Regulation:** [21 CFR 882.5804](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5804)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QWI/DEN220083.md) | Stanza | Swing Therapeutics, Inc. | May 9, 2023 | DENG |

## Top Applicants

- Swing Therapeutics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QWI](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QWI)

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