| Device |
thermal vestibular stimulator for headache |
| Regulation Description |
Thermal vestibular stimulator for headache. |
| Definition |
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache. |
| Physical State |
The device resembles a pair of over-the-ear headphones consisting of a headband, padded ear covers, and anodized aluminum ear pieces with are inserted in the external ear canal. The device contains an accompanying unit for device control and a mains power supply. |
| Technical Method |
The device produces a regulated thermal waveform which provides simultaneous heating in one ear and cooling in the other ear. The controlled temperature changes activate the vestibular system. |
| Target Area |
The device is used in the external ear canals to stimulate the vestibular system. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QAR |
|---|
| Premarket Review |
Neuromodulation and Rehabilitation Devices
(DHT5B)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5893
|
|---|
| 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 |
