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510(k) Data Aggregation

    K Number
    K992310
    Device Name
    TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
    Manufacturer
    RUPIANI MEDICAL
    Date Cleared
    1999-11-02

    (116 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are tricycles that are indicated for use with people, from children to adults, some of whom may have motor disabilities.

    Device Description

    These devices are tricycles

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "TONICROSS Tricycles." This document is a regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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