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510(k) Data Aggregation

    K Number
    K152021
    Device Name
    Pure Tilt
    Date Cleared
    2016-03-31

    (254 days)

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

    Proactive Comfort, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features: - A tilting seat with adjusting capability up to 45°; - User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring piston; - Hinged, non-detachable armrests that swing upward and toward the back to facilitate transfer of a subject into or out of the wheelchair; - Built-in housing for compatible transfer board; - Mechanical armrest locks that secure the armrests to be used safely as handles for lifting the wheelchair with the user in it; - Two 21" diameter rear wheels with aluminum hand-rims for self-propelling; - Two 6" diameter front casters that swivel for easy maneuvering; - Adjustable seat-to-floor height (2 Settings: 19" and 17"); - Angle-adjustable leg-rest assembly with the following features: - Foot platform that swings upward to facilitate stowage . - Telescoping adjustable height . - User-operated mechanism to adjust leg-position angle, which is assisted by mechanical spring piston; - Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and - Headrest with adjustable vertical position.
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