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510(k) Data Aggregation

    K Number
    K071006
    Device Name
    HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
    Manufacturer
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2007-05-21

    (42 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K070489
    Why did this record match?
    Device Name :

    HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1

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

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    The HEARTWAY Attendant-Controlled Power Chair, TC1 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. Based on the document, it is a 510(k) summary for a powered wheelchair (HEARTWAY Attendant-Controlled Power Chair, TC1) that aims to establish substantial equivalence to a predicate device.

    The document mentions:

    • Performance Testing: "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)". These are standards that the device was tested against.
    • Substantial Equivalence Comparison: The new device (TC1) is compared to the HEARTWAY Power Tilt Seating System Power Chair, P16RT (K070489). The comparison focuses on intended use, materials, strength and fatigue tests, incline degree, suspension, footplates, armrest type, warranty, upholstery material (passed resistance ignition test), and electronic systems (UL certified).

    However, the document does not provide:

    1. A table of specific acceptance criteria values and the device's reported performance against those criteria.
    2. Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set or ground truth establishment.
    3. Information about MRMC studies, standalone algorithm performance, or training set details.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and a detailed study description based on the provided text.

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