External Compression Device For Internal Jugular Vein Compression
The External Compression Device for Internal Jugular Vein Compression is a non-invasive neurology device intended to increase intracranial blood volume by applying gentle external compression to the internal jugular vein, thereby reducing the occurrence of specific brain changes following head impacts in applicable environments of use such as contact sports. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 890.3050 in the Neurology specialty. It carries product code QNX and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNX
- Device Class
- FDA class 2
- Regulation Number
- 890.3050
- Medical Specialty
- Neurology
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200017 | Q-Collar | Feb 26, 2021 | Unknown | Q30 Sports Science, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.