BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    WAVELENGHT ULTRASOUND LOTION

    K Number: K013212 · Decision Feb 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    WAVELENGHT ULTRASOUND LOTION
    K Number
    K013212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Therapy Products, Inc.
    Date Received
    September 25, 2001
    Decision Date
    February 25, 2002
    Product Code
    MUI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUI Media, Coupling, Ultrasound

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    Other Clearances by National Therapy Products, Inc.

    K Number Device Name
    K012522 WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL