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510(k) Data Aggregation

    K Number
    K012580
    Device Name
    ERCHONIA PL2000
    Manufacturer
    TUCO INNOVATIONS, INC.
    Date Cleared
    2002-01-17

    (161 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TUCO INNOVATIONS, INC.

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

    The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "TUCO Erchonia PL3000" (though listed as PL2000 in the Indications for Use section). It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    However, the provided text does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications. The letter primarily serves as a notification of clearance and refers to the device's substantial equivalence to a predicate device for its indicated use.

    Therefore, I cannot fulfill your request for the detailed information asked for in points 1 through 9 based on the provided text. The document is a regulatory approval, not a scientific study report.

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