OVP

Vibratory Counter-Stimulation

Product code: OVP
Device name: Vibratory Counter-Stimulation
Device class: Class 2
21 CFR: 21 CFR 882.5895
Medical specialty: Physical Medicine
Marketing pathway: 510(K) Exempt
510(k) clearances (last 3 years): 1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OVP

Classification and pathway per current FDA publications. Data from openFDA (CC0).