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510(k) Data Aggregation

    K Number
    K191334
    Device Name
    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
    Manufacturer
    MATIA Robotics (US) Inc
    Date Cleared
    2020-05-29

    (378 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

    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) Models: TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD06, TEKRMD06, TEKRMD07, TEKRMD08

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE). This document does not contain any information about acceptance criteria, device performance, clinical study design, or ground truth establishment relevant to an AI/ML medical device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval, product codes, and general controls, rather than a performance evaluation of the device based on specific criteria.

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