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510(k) Data Aggregation

    K Number
    K101217
    Device Name
    MAC-MOBILE AQUATIC CHAIR
    Manufacturer
    Date Cleared
    2010-06-23

    (54 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REHAMED INTL. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transferring individuals into a swimming pool via a ramp.
    Device Description
    The MAC-Mobile Aquatic Chair features a rigid frame design and is suitable to provide mobility both indoors and in wet conditions. Primarily designed to assist non-ambulatory users to gain entry to a swimming pool via a ramp, the Aquatic Wheelchair features anti-tip wheels that are built into the design. The MAC-Mobile Aquatic Chair is fabricated from stainless steel that is coated with a tough powder coated finish. The wheels and casters are made from a water friendly plastic material. The rigid plastic seat is specifically designed for use in an aquatic environment. The entire product can be submersed into pool water with no harmful effects. The User's Manual provides information on warnings, maintenance, and operating instructions.
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