meddevicedb.com FDA Device Reference

Q-Collar

DEN200017 Class II Direct
Decision Date
2021-02-26
Sponsor / Applicant
Q30 Sports Science, LLC

Technical Specification

510(k) Submission ID DEN200017
Product Code QNX
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 890.3050
Decision Date 2021-02-26
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Q-Collar received FDA 510(k) clearance under submission number DEN200017, sponsored by Q30 Sports Science, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-02-26.

Classification & Regulation

This clearance is catalogued under FDA product code QNX and 21 CFR 890.3050, within the Neurology review panel as a Class II device.