FDA product code OVP

Vibratory Counter-Stimulation

Physical Medicine·Class 2·21 CFR 882.5895
US regulatory classifications
US Product Code (FDA)
OVP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5895
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Vibratory Counter-Stimulation is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.