POP

Cranial Motion Measurement Device

Product code

POP

Device name

Cranial Motion Measurement Device

Device class

Class 2

21 CFR

21 CFR 882.1630

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).