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510(k) Data Aggregation

    K Number
    K981449
    Device Name
    SD-956 ULTRASOUND THERAPY
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-12-11

    (233 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SD-956 ULTRASOUND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SD-956 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

    Device Description

    SD-956 Ultrasound Therapy

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the SD-956 Ultrasound Therapy device. It does not contain information about acceptance criteria, study details, or device performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of use detailed in the enclosure.

    Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from the provided text.

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