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510(k) Data Aggregation

    K Number
    K111636
    Device Name
    REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
    Manufacturer
    Date Cleared
    2012-04-03

    (295 days)

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

    GUNNELL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose of The Gunnell Rehab Series Wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. The Kidster is the only device in the GRSW that is solely intended for pediatric users. The intended use of all of the GRSW's is to provide mobility to individuals restricted to a sitting position.
    Device Description
    The Gunnell Rehab Series of Wheelchairs (GRSW) are manually operated, mechanical wheelchairs. The GRSW are fabricated from materials common to many other wheelchairs in the industry. In addition, the GRSW offer the same options and exhibit the same features as many other mechanical wheelchairs in the market. The entire GRSW feature a recline function. The TNT. MAC, and Kidster include a tilt in space feature, which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt feature can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access. The TNT, RAM, and Kidster also have an optional lateral tilt feature allowing for 20° lateral tilt to the right and left. The lateral tilt feature is helpful in positioning individuals with a number of different conditions. For example, this feature allows for the seat to be on a lateral angle in response to the angle or degree of scoliosis exhibited by the user thereby providing better positioning for long term usage. The TNT and the RAM are available in bariatric sizes, featuring the same options and construction as that of their respective standard models.
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