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.
| Device Type ID | 3792 |
| Device Name | Cranial Motion Measurement Device |
| 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 Clini |
| 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 Description | Cranial Motion Measurement Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3792 |
| Device | Cranial Motion Measurement Device |
| Product Code | POP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cranial Motion Measurement Device. |
| CFR Regulation Number | 882.1630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
JAN MEDICAL, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |