510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POPClass II

Cranial Motion Measurement Device

21 CFR 882.1630 / Neurology
FDA source (opens on fda.gov)

POP is the FDA product code for Cranial Motion Measurement Device, a class II device type, regulated under 21 CFR 882.1630. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
POP
Device name
Cranial Motion Measurement Device
FDA 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.
Regulation
21 CFR 882.1630
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code POP

By decision year
2 clearances under product code POP with a decision year between 2016 and 2017, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code POP by decision year
YearClearances
20161
20171

Applicants with the most clearances

Product code POP
Applicants holding the most 510(k) clearances under product code POP
ApplicantClearances
Jan Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code POP.