| Device |
vibratory counter-stimulation |
| Regulation Description |
Vibratory counter-stimulation device. |
| 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. |
| Physical State |
vibrating pad |
| Technical Method |
Applies a mechanical vibration to the lower legs |
| Target Area |
Lower legs |
| Regulation Medical Specialty |
Physical Medicine |
| Review Panel |
Neurology |
|---|
| Product Code | OVP |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
882.5895
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
