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510(k) Data Aggregation

    K Number
    K221435
    Device Name
    SUPERTILT PLUS (STP)
    Date Cleared
    2022-10-28

    (164 days)

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

    Power Plus Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use for the manual (mechanical) wheelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.
    Device Description
    A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only. As oppose to the standard wheelchair properties, the Supertilt Tilt main feature can tilt in space for up to 33 degrees using two gas cylinders that can support up to 250 lbs. The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel. In terms of biocompatibility, the main direct contact components on long periods in time with the user/client are the arm rest pad, cushion back cushion, headrest pad and footrest padding. Transient contacts with the user/client include arm skirt guard, arm tube, arm socket and footrest tube. The Supertilt Plus in its final finished form is identical to the Concept 45, Invacare, K951138, cleared on 3/20/1995 (legally US marketed device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers. device) in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
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