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510(k) Data Aggregation

    K Number
    K220990
    Device Name
    Qorda QD1
    Manufacturer
    Winix Inc.
    Date Cleared
    2022-09-14

    (163 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Winix Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qorda QD is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Fan Speed | Average Maximum log<br>reduction | Exposure Time | |----------------------------------------|------------|----------------------------------|---------------| | MS2 bacteriophage | Turbo MODE | 5.6 log reduction | 20 minutes | | MS2 bacteriophage | Sleep MODE | 4.9 log reduction | 45 minutes | | <i>Bacillus subtilis</i><br>endospores | Turbo MODE | 4.4 log reduction | 20 minutes | | <i>Bacillus subtilis</i><br>endospores | Sleep MODE | 4.3 log reduction | 60 minutes |
    Device Description
    Oorda OD1 is a freestanding medical recirculation air cleaner that facilitates movement with wheels. The device includes two pre-filters, two deodorizing filters, two HEPA filters - 3 filters in the front panel and 3 filters in the rear panel), and a manual for users. The device can adjust the air volume in four stages through manual operation (Level 1, Level3, Turbo) and Sleep mode. When operating in sleep mode, the equipment LED and PlasmaWave are turned off and operated with low noise. The device contains the following additional functions. (1)Child lock: Button lock function that prevents children or pets from changing their current motion mode even if they accidentally operate device. (2)Filter Replacement Guide: The remaining filter life is displayed on the front display of the device and tells you when to replace the filter. (3)Adjustment of illuminance: You can adjust the illuminance in four stages (100%, 50%, 20%, OFF). (4)You can turn on or off the PlasmaWave. (5)The timer allows the equipment to turn off automatically after a certain period of time. Qorda QD1 inhales air in both directions on the front and rear of the device and purifies it through the four cleaning steps below: [Pre-Filter] The air is drawn in through the cover front, passes through the Pre-Filter then moves to two filters stages(CD Carbon Filter, True HEPA Filter). The Pre-Filter protects CD Carbon Filter, True HEPA Filter inside the Pre-Filter. [CD Carbon Filter] Reduces any ozone generated as a byproduct of the plasma field. It also prolongs the True HEPA Filter lifespan. [True HEPA Filter] True HEPA Filter captures 99.99%* of airborne ultrafine particles as small as 0.003 microns. *Based on independent laboratory test conducted on particles as small as 0.003 microns in size. [PlasmaWave] PlasmaWave Technology has been tested by an independent third-party to remove particles from the air for medical purposes.
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