FDA product code OVP: Vibratory Counter-Stimulation
OVP is the FDA product code for vibratory counter-stimulation. It is a Class II device, regulated under 21 CFR 882.5895 and reviewed by the Neurology panel. Devices under OVP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.
Classification
| Field | Value |
|---|---|
| Device name | Vibratory Counter-Stimulation |
| Device class | Class II |
| Regulation | 21 CFR 882.5895 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for OVP devices
openFDA lists no recalls for product code OVP.
Frequently asked questions
What is FDA product code OVP?
OVP is the FDA product code for vibratory counter-stimulation. It is a Class II device, regulated under 21 CFR 882.5895 and reviewed by the Neurology panel.
What device class is OVP?
Class II, regulation 21 CFR 882.5895. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OVP
- Run a recall and safety report across every OVP manufacturer
- Watch product code OVP 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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