BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MamaLift Plus

    K Number: K223515 · Decision Apr 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    517

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    Basic Information

    Device Name
    MamaLift Plus
    K Number
    K223515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5801
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curio Digital Therapeutics, Inc.
    Date Received
    November 22, 2022
    Decision Date
    April 22, 2024
    Product Code
    SAP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAP Computerized Behavioral Therapy Device For Depressive Disorders.

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