FDA product code QWI: Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
QWI is the FDA product code for computerized behavioral therapy device for the treatment of fibromyalgia symptoms. It is a Class II device, regulated under 21 CFR 882.5804 and reviewed by the Physical Medicine panel. Devices under QWI reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms |
| Device class | Class II |
| Regulation | 21 CFR 882.5804 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QWI devices
openFDA lists no recalls for product code QWI.
Frequently asked questions
What is FDA product code QWI?
QWI is the FDA product code for computerized behavioral therapy device for the treatment of fibromyalgia symptoms. It is a Class II device, regulated under 21 CFR 882.5804 and reviewed by the Physical Medicine panel.
What device class is QWI?
Class II, regulation 21 CFR 882.5804. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QWI
- Run a recall and safety report across every QWI manufacturer
- Watch product code QWI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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