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510(k) Data Aggregation

    K Number
    K252687

    Validate with FDA (Live)

    Device Name
    Manual Wheelchair (HM305-Air1, HM305-Air2)
    Manufacturer
    Suzhou Master Machinery Manufacturing Co., Ltd.
    Date Cleared
    2025-11-21

    (87 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

    The manual wheelchair is to provide mobility to persons limited to a sitting position.

    Device Description

    Manual Wheelchair (HM305-Air1, HM305-Air2)

    AI/ML Overview

    N/A

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