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510(k) K220990

Qorda QD1 by Winix, Inc. — Product Code FRF

K220990 is an FDA 510(k) premarket notification submitted by Winix, Inc. for the device "Qorda QD1". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2022
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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FDA data resources