DeviceClearance

Product code POP— Neurology

BrainPulse 1100

Classification name
Cranial Motion Measurement Device
Device class
Class 2
Regulation
21 CFR 882.1630
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code POP under 21 CFR 882.1630, via openFDA

Market context for product code POP

FDA has cleared 2 devices under product code POP between 2016 and 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code POP

Recent clearances under product code POP

Data sourced from openFDA. This site is unofficial and independent of the FDA.