OVP — Vibratory Counter-Stimulation Class II
FDA product code OVP covers "Vibratory Counter-Stimulation", a Class II medical device regulated under 21 CFR 882.5895. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OVP
- Device Class
- Class II
- Regulation Number
- 882.5895
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN110011 | sensory medical | SYMPHONY DEVICE | December 18, 2013 |