Product code POP

Device name

Cranial Motion Measurement Device

Medical specialty

Neurology

Device class

2

Regulation number

882.1630

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset