QWI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5804
- Medical specialty
- Neurology
- FDA definition
- Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
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| Record | Firm | Date |
|---|---|---|
| Stanza (DEN220083) | Swing Therapeutics, Inc. | 2023-05-09 |
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