DEN220083 is an FDA 510(k) submission for the Stanza. This device is classified as a Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms (Class II - Special Controls, product code QWI).
Submitted by Swing Therapeutics, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5804. Provides Acceptance And Commitment Therapy (act), A Form Of Cognitive Behavioral Therapy (cbt), For Patients With Fibromyalgia Symptoms.
| 510(k) Number | DEN220083 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 21, 2022 |
| Decision Date | May 09, 2023 |
| Days to Decision | 169 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QWI - Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5804 |
| Definition | Provides Acceptance And Commitment Therapy (act), A Form Of Cognitive Behavioral Therapy (cbt), For Patients With Fibromyalgia Symptoms |