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510(k) Data Aggregation

    K Number
    K973914
    Device Name
    SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
    Manufacturer
    SENSE TECHNOLOGY, INC.
    Date Cleared
    1998-06-30

    (259 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENSE TECHNOLOGY, INC.

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

    Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called PulStarFRAS, indicating that it has been found substantially equivalent to a previously marketed device. It lists the indications for use but does not detail any performance metrics, studies, or acceptance criteria.

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