LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982750
    Device Name
    CORSAIRE
    Manufacturer
    OPTIWAY, INC.
    Date Cleared
    1999-02-01

    (179 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K945936
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls. The device has similar features and uses as the predicated devices; "Jazzy" (K945936) Electric Powered Wheelchair manufactured by Pride Health Care. This device has the same intended use, safety and effectiveness as the predicated device mentioned.

    Device Description

    This device is a electric powered wheelchair for indoor use, to be used by artially disabled people capable of operating a few essential hand controls.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "Corsaire." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document only states that the device is substantially equivalent to a predicate device ("Jazzy" K945936) and can be marketed.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1