QNX — External Compression Device For Internal Jugular Vein Compression Class II

FDA Device Classification

FDA product code QNX covers "External Compression Device For Internal Jugular Vein Compression", a Class II medical device regulated under 21 CFR 890.3050. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QNX
Device Class
Class II
Regulation Number
890.3050
Submission Type
Review Panel
PM
Medical Specialty
Neurology
Implant
No

Definition

External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN200017q30 sports scienceQ-CollarFebruary 26, 2021