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510(k) Data Aggregation

    K Number
    K163451
    Date Cleared
    2018-01-12

    (400 days)

    Product Code
    Regulation Number
    890.3900
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Action Trackstander models TR1816, TR1820, TR2016, and TR2020

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

    The Action Trackstander all-terrain power wheelchair with the integrated stand-up position function provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and cannot stand up on their own. The Action Trackstander does not require a doctor's prescription.

    Device Description

    Action Trackstander models Tr1816. Tr1820. Tr2016. and Tr2020

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for Action Manufacturing Inc.'s Action Trackstander power wheelchairs. It primarily concerns regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details. This document is a regulatory communication, not a scientific or clinical study report.

    Therefore, I cannot fulfill your request for that specific information based on the provided text.

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