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.
| Device Type ID | 3823 |
| Device Name | Vibratory Counter-stimulation |
| Physical State | Vibrating Pad |
| Technical Method | Applies A Mechanical Vibration To The Lower Legs |
| Target Area | Lower Legs |
| Regulation Description | Vibratory Counter-stimulation Device. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 882.5895 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3823 |
| Device | Vibratory Counter-stimulation |
| Product Code | OVP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vibratory Counter-stimulation Device. |
| CFR Regulation Number | 882.5895 [🔎] |