| Device |
external compression device for internal jugular vein compression |
| Definition |
External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use. |
| Physical State |
A plastic neck collar with protuberances located at each end of the device. |
| Technical Method |
The device is designed to lightly compress the sternocleidomastoid muscles in the neck, which is designed to provide compressive force to the internal jugular vein (IJV). The restriction in blood flow is designed to result in an increase in the volume of blood in the venous capacitance vessels within the skull. Whereas the brain generally has room to move slightly within the skull, the increased blood volume is intended to create a tighter fit and reduce intracranial movements within the skull. This is intended to reduce the movement of the brain within the cranial space, the device may aid in the protection of the brain from the effects of head impacts. |
| Target Area |
Neck |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Physical Medicine |
|---|
| Product Code | QNX |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
890.3050
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
