510(k) DEN110011
DEN110011 is an FDA 510(k) premarket notification submitted by Sensory Medical, Inc. for the device "SYMPHONY DEVICE". The FDA issued a decision of De Novo Granted on December 18, 2013. The device falls under product code OVP (Vibratory Counter-Stimulation), a Class II device regulated under 21 CFR 882.5895.
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.