# Vibratory Counter-Stimulation
> **Product code: OVP** · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 882.5895
## Classification
- **FDA Product Code:** OVP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.5895
- **Review panel:** NE
- **Medical specialty:** Physical Medicine
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OVP)
---
*AI Analytics · CC0 1.0*