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510(k) Data Aggregation

    K Number
    K032133
    Device Name
    BRODA MODEL 587 MANUAL WHEELCHAIR
    Manufacturer
    Date Cleared
    2003-07-21

    (10 days)

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

    BRODA ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Broda Model 587 Manual Wheelchair is to provide mobility to persons that may be limited to a sitting position.
    Device Description
    The Model 587 Broda Manual Wheelchair is a manually operated, user propelled mechanical wheelchair. The intended use is to provide mobility to persons that may be limited to a sitting position. The product consists primarily of a rigid steel frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. This is a non-folding rigid type of wheelchair which can be customized for use by patients that weigh up to 250 lbs. Seat width ranges from a minimum of 14'' wide to a maximum of 20'' wide in two inch increments, with the 16" and 18" widths offered as standard. Seat depths range from a minimum of 15.5" deep to a maximum of 20" deep in 1.5" increments, with the 17" depth offered as standard. Seat to floor dimensions range from 15'' high to 20'' high in 1" increments, with the 19" height offered as standard. Back height ranges from a minimum of 24" high to a maximum of 32" high in 2" increments, with the 24" height offered as standard. The rigid frame is constructed of round, steel tubing that is MIG welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 0.065". A rigid, non-folding frame is not used on the predicate device and does not affect the safety and effectiveness of the chair. The Broda Model 587 Wheelchair offers up to 22 degrees of seat tilt with infinite positioning. The seat tilt controls slumping and sliding, reduces the reliance on restraints, and increases the general comfort level for the occupant. This specification is not available on the predicate devices and does not affect the safety and effectiveness of the chair. The seat and back are strapped with vinyl strapping that is riveted to the steel tube. The strap is 0.128" thick and 1.5" wide. The strapping is used to better distribute the weight of the occupant, hence reduce the contact pressures on the occupant, which provides added comfort. The strapping also controls heat and moisture buildup and can prevent skin breakdown. The strapping is further covered with a woven polyester/spandex material called Triptex. The strapping is not used on the predicate device and does not affect the safety and effectiveness of the chair.
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