FDA product code SEE: Computerized Behavioral Therapy Device For Migraine
SEE is the FDA product code for computerized behavioral therapy device for migraine. It is a Class II device, regulated under 21 CFR 882.5806 and reviewed by the Neurology panel. Devices under SEE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For Migraine |
| Device class | Class II |
| Regulation | 21 CFR 882.5806 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SEE devices
openFDA lists no recalls for product code SEE.
Frequently asked questions
What is FDA product code SEE?
SEE is the FDA product code for computerized behavioral therapy device for migraine. It is a Class II device, regulated under 21 CFR 882.5806 and reviewed by the Neurology panel.
What device class is SEE?
Class II, regulation 21 CFR 882.5806. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SEE
- Run a recall and safety report across every SEE manufacturer
- Watch product code SEE 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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