POP — Cranial Motion Measurement Device Class II
FDA product code POP covers "Cranial Motion Measurement Device", a Class II medical device regulated under 21 CFR 882.1630. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- POP
- Device Class
- Class II
- Regulation Number
- 882.1630
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.