DeviceClearance

Product code OVP— Physical Medicine

SYMPHONY DEVICE

Classification name
Vibratory Counter-Stimulation
Device class
Class 2
Regulation
21 CFR 882.5895
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OVP under 21 CFR 882.5895, via openFDA

Market context for product code OVP

FDA has cleared 1 device under product code OVP, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OVP

Recent clearances under product code OVP

Data sourced from openFDA. This site is unofficial and independent of the FDA.