Device |
cranial motion measurement device |
Definition |
A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes. |
Physical State |
Accelerometer hardware. May include headset to aid in positioning. May include additional sensors (e.g. photoplethysmography). May include hardware and software to allow for data collection and review. Does not include software that outputs any clinical interpretation of the data. |
Technical Method |
Uses a headset containing accelerometers positioned around the head to measure motion or acceleration, and may use a photoplethysmography sensor to detect heartbeat. |
Target Area |
Head |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | POP |
Premarket Review |
Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.1630
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|