510(k) DEN110011

SYMPHONY DEVICE by Sensory Medical, Inc. — Product Code OVP

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 18, 2013
Date Received: July 13, 2011
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Vibratory Counter-Stimulation
Device Class: Class II
Regulation Number: 882.5895
Review Panel: NE
Submission Type

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.