Cranial Motion Measurement Device
The Cranial Motion Measurement Device (product code POP) is a Class 2 neurology prescription device that utilizes accelerometers to measure the motion or acceleration of the skull, regulated under 882.1630. These measurements are explicitly not to be used for diagnostic purposes. The device requires 510(k) clearance and is not an implant or life-sustaining product.
Research product code POP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- POP
- Device Class
- FDA class 2
- Regulation Number
- 882.1630
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.