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510(k) Data Aggregation

    K Number
    K242354
    Device Name
    AllNEB
    Manufacturer
    Enchant Tek Co. Ltd.
    Date Cleared
    2025-04-29

    (264 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enchant Tek Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
    Device Description
    AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.
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    K Number
    K233855
    Device Name
    AllPEP
    Manufacturer
    Enchant Tek Co. Ltd.
    Date Cleared
    2024-02-02

    (59 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enchant Tek Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.
    Device Description
    AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well. Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.
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