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510(k) Data Aggregation

    K Number
    K983681
    Device Name
    DOMINATOR
    Manufacturer
    IMPACT WHEELCHAIR MANUFACTURE, INC.
    Date Cleared
    1998-11-27

    (38 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

    The intended use of the device is in providing mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Dominator," manufactured by Impact Wheelchair Manufacture Inc. It declares the device substantially equivalent to a predicate device but does not contain information on acceptance criteria or a study proving the device meets these criteria. Therefore, I cannot provide the requested information based on this document.

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