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OVP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Vibratory Counter-Stimulation
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5895
Medical specialty
Physical Medicine
FDA 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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RecordFirmDate
SYMPHONY DEVICE (DEN110011)Sensory Medical, Inc.2013-12-18

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