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510(k) Data Aggregation

    K Number
    K222416
    Device Name
    RIA Safeguard
    Manufacturer
    RIA Tech Co., Ltd.
    Date Cleared
    2023-05-01

    (264 days)

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

    RIA Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RIA SafeGuard is intended as a room recirculating air cleaner. The system is used for filtering out airborne particles PM2.5 from the air for medical purposes, and is intended for over-the-counter use. The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m3/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m³ room.
    Device Description
    RIA SafeGuard (SG020MS120) is an air purifier that contains the highefficiency HEPA technology and Bi-Polar Ionization (BPI) unit to remove 99.99% of particles as small as 2.5 microns from the air stream. SafeGuard addresses suspended particles with a single wind speed of 1.3 m/s, providing a 4 log reduction in PM2.5 particulates within 120 minutes in a 29.75 m³ space. The airflow is 135 CMH (m3/h). It is intended to be placed in a room such as medical care institutions and hospitals etc. RIA SafeGuard is a product that is designed as one-touch, easy to use, and no contact with patients. RIA SafeGuard has built in a blue LED as the switch-on indicator. All the maintenance should be done by a trained technician. Changing the HEPA is the only recommended maintenance to do by a non-trained technician, recommended renewing every 12 months.
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