# DEN220083: Stanza

- Pathway: De Novo (Direct)
- Applicant: Swing Therapeutics, Inc.
- Decided: May 9, 2023 after 169 days
- Product code: QWI (Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms)
- Device class: 2
- Regulation: 21 CFR 882.5804
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN220083
Methodology: https://510kreport.com/methodology