QWI — Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms Class II
FDA product code QWI covers "Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms", a Class II medical device regulated under 21 CFR 882.5804. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWI
- Device Class
- Class II
- Regulation Number
- 882.5804
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Neurology
- Implant
- No
Definition
Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220083 | swing therapeutics | Stanza | May 9, 2023 |