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510(k) Data Aggregation

    K Number
    K211647
    Device Name
    HP358EA Electrically Powered Wheelchair
    Manufacturer
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Date Cleared
    2022-01-04

    (221 days)

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

    HP358EA Electrically Powered Wheelchair

    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 sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) clearance letter for an electrically powered wheelchair. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria, as one would find for a diagnostic or AI-enabled medical device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, which are not part of this 510(k) clearance letter.

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