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510(k) Data Aggregation

    K Number
    K163280
    Device Name
    RP Lite 760R
    Manufacturer
    Date Cleared
    2017-01-27

    (67 days)

    Product Code
    Regulation Number
    890.5650
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RP Lite 760R

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

    The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health.

    The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RP Lite 760R". It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The FDA 510(k) clearance process primarily establishes substantial equivalence based on indications for use, technological characteristics, and safety/effectiveness data compared to a predicate device. It does not typically detail the specific performance metrics, acceptance criteria, or the results of the rigorous clinical or technical studies that would be necessary to populate a table like the one requested.

    Therefore, I cannot fulfill your request using only the provided text, as the information you're asking for (acceptance criteria, specific study details, sample sizes, ground truth establishment, etc.) is not present in this regulatory clearance letter.

    To answer your question, information from a separate submission document (e.g., the 510(k) submission itself, a clinical study report, or a technical performance evaluation document) would be required.

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