Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011745
    Date Cleared
    2001-08-30

    (85 days)

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

    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

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

    The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.

    Device Description

    Model HP-3, Power Wheelchair

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a power wheelchair (Model HP-3). This document does not contain the information requested for acceptance criteria and study details for a medical device's performance.

    The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls, but not specific performance criteria or a study demonstrating achievement of those criteria.

    Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1