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510(k) Data Aggregation

    K Number
    K980107
    Device Name
    RUNCH INDUSTRIAL WHEELCHAIR
    Manufacturer
    RUNCH GROUP USA, INC.
    Date Cleared
    1998-02-19

    (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

    A mechanical, manual, foldable wheelchair which can be used in a residential environment, managed care or public facility. This device is for incapacitated and partially incapacitated persons requiring mobility in a sitting position. The device can be operated by using downward (forward) strokes or upward (backward) strokes by the operator on the hand rim steering device attached to an made part of the wheel. To turn left or right, apply pressure on the hand rim. The device can also be powered by an attendant pushing the device with the two (left and right) rear handles. Brakes are located on either side of each wheel and can operated by the left or right hand. Expendable energy is minimal and efficient when traveling short distances.

    Device Description

    A mechanical, manual, foldable wheelchair.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, dated February 19, 1998. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed, subject to general controls.

    Therefore, I cannot provide the requested information based on the provided text.

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