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510(k) Data Aggregation

    K Number
    K150548
    Device Name
    Tek RMD (Tek Robotic Mobilization Device)
    Manufacturer
    MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN ve TIC.A.S
    Date Cleared
    2015-06-11

    (100 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.

    Device Description

    The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.

    AI/ML Overview

    This FDA 510(k) clearance letter for the Tek RMD (Robotic Mobilization Device) does not contain specific details about acceptance criteria, device performance results, or a detailed study description as typically found in an AI/ML device submission summary.

    The document is a clearance letter from the FDA to Matia Robotics, indicating that their device has been found substantially equivalent to a legally marketed predicate device. This type of document confirms regulatory clearance but does not delve into the granular technical details of performance evaluation for AI/ML devices.

    Therefore, the requested information cannot be extracted from the provided text. To answer your questions, one would need to access the actual 510(k) submission summary for K15058, which would contain the performance study details.

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