Product code OVP

Device name

Vibratory Counter-Stimulation

Medical specialty

Physical Medicine

Device class

2

Regulation number

882.5895

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset