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510(k) Data Aggregation

    K Number
    K243023
    Device Name
    WiZARD 520 Full Face Mask
    Manufacturer
    Wellell Inc.
    Date Cleared
    2025-05-23

    (238 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wellell Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment. The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.
    Device Description
    WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability. WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.
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