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510(k) Data Aggregation

    K Number
    K030880
    Date Cleared
    2003-04-18

    (29 days)

    Product Code
    Regulation Number
    890.5860
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VECTORSONIC, MODEL VU-270

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

    The indications for use for the interferential therapy are:

    • Relaxation of muscle spasm: 1.
      1. Prevention or retardation of disuse atrophy:
      1. Increasing local blood flow;
      1. Muscle re-education;
    • Immediate post-surgical stimulation of calf muscles to prevent 5. venous thrombosis; and
    • Maintaining or increasing range of motion. 6.

    The indications for use for the ultrasound therapy are:

      1. Relief or reduction of pain;
      1. Reduction of muscle spasm;
      1. Joint contracture; and
      1. Local increase in circulation.

    The indication for use for the combined therapy is:

    • Reduction of muscle spasm. 1.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Vectorsonic Model VU 270. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Specifically, the document:

    • Identifies the device (Vectorsonic Model VU 270) and its manufacturer.
    • States the regulation number, name, and regulatory class for the device (Ultrasound and muscle stimulator, Class II).
    • Lists the indications for use for interferential therapy, ultrasound therapy, and combined therapy.
    • Confirms the FDA's finding of substantial equivalence.

    Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory approval, not a technical report detailing performance study results.

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