OVPClass II
Vibratory Counter-Stimulation
21 CFR 882.5895 / Physical Medicine
OVP is the FDA product code for Vibratory Counter-Stimulation, a class II device type, regulated under 21 CFR 882.5895. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OVP
- Device name
- Vibratory Counter-Stimulation
- 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.
- Regulation
- 21 CFR 882.5895
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OVP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
Applicants with the most clearances
Product code OVP| Applicant | Clearances |
|---|---|
| Sensory Medical Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OVP.
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