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510(k) Data Aggregation

    K Number
    K063475
    Device Name
    IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
    Manufacturer
    IMC-HEARTWAY, LLC
    Date Cleared
    2007-01-23

    (68 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)

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

    The intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair (IMC-Heartway, LLC Model-Tiara (P4AS)). It confirms substantial equivalence to a predicate device and allows the device to be marketed.

    The document does not contain any information about acceptance criteria, studies, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML powered medical device. The information requested pertains to the evaluation of AI/ML performance, which is not applicable to this 510(k) clearance for a powered wheelchair.

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