OVP — Vibratory Counter-Stimulation Class II

FDA Device Classification

Classification Details

Product Code
OVP
Device Class
Class II
Regulation Number
882.5895
Submission Type
Review Panel
NE
Medical Specialty
Physical Medicine
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN110011sensory medicalSYMPHONY DEVICEDecember 18, 2013