POP · Class II · 21 CFR 882.1630

FDA Product Code POP: Cranial Motion Measurement Device

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.

Leading manufacturers include Jan Medical, Inc..

2
Total
1
Cleared
309d
Avg days
2016
Since

FDA 510(k) Cleared Cranial Motion Measurement Device Devices (Product Code POP)

2 devices
1–2 of 2
Cleared Apr 28, 2017
BrainPulse 1100
K170926
Jan Medical, Inc.
Neurology · 30d
Not Cleared Aug 01, 2016
Nautilus BrainPulse 1000
DEN140040
Jan Medical, Inc.
Neurology · 587d

About Product Code POP - Regulatory Context