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510(k) Data Aggregation

    K Number
    K011744
    Date Cleared
    2001-08-24

    (80 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

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

    The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.

    Device Description

    Model HP-5, Power Wheelchair

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a power wheelchair, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device but does not detail studies or acceptance criteria for the Model HP-5.

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