Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
The computerized behavioral therapy device for the treatment of fibromyalgia symptoms (product code QWI) is a software-based Class 2 device in the Neurology specialty (regulation 882.5804) that provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), to patients with fibromyalgia symptoms. It requires 510(k) clearance. The device is a digital therapeutic tool and is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- QWI
- Device Class
- FDA class 2
- Regulation Number
- 882.5804
- Medical Specialty
- Neurology
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
Definition
Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220083 | Stanza | May 09, 2023 | Unknown | Swing Therapeutics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.