DEN200017 is an FDA 510(k) submission for the Q-Collar. This device is classified as a External Compression Device For Internal Jugular Vein Compression (Class II - Special Controls, product code QNX).
Submitted by Q30 Sports Science, LLC (Westport, US). The FDA issued a Not Cleared (DENG) decision on February 26, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3050. 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) Number | DEN200017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 19, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 344 days |
| Submission Type | Direct |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | QNX - External Compression Device For Internal Jugular Vein Compression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3050 |
| 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. |