Vibratory Counter-Stimulation

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown