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 (all years, FDA)

1 (all years; only the last 3 years are listed here)

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).