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510(k) Data Aggregation

    K Number
    K140416
    Device Name
    TREKKER, TREKKER TRANSIT
    Date Cleared
    2014-09-17

    (211 days)

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

    CONVAID PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Convaid Trekker models are manual wheelchairs; Their intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position. In addition the Trekker models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.
    Device Description
    The Trekker TR12, TR12T and TR14, TR14T are attendant propelled manual wheelchairs. They are lightweight compact folding wheelchairs with tubular 6061 aluminum frames with removable seating modules for easy transport and stowage. The seating module is also reversible to allow the caregiver the option to observe the user during use. Front small casters for steering and maneuverability and larger wheels in the rear. A tilt function for pressure relief and the recline function provide adjustability for the lower extremities. Foot operated wheel locks provide easy operation. Positioning options include H-harness, two point seat belt, three point seat belt with crotch pad additional non-positioning accessories include under seat storage basket, adjustable I.V. Pole. Trekker transit option TR12T and TR14T transit models are identical to the TR12 and TR14 except for the factory installation of four (4) tie-down anchors and required labeling. They meet the requirements for use as seating in motor vehicles when used in conjunction with the vehicle supplied four (4) wheelchair tie-down system that attaches to the four (4) transport anchors on the wheelchair and a three (3) point occupant restraint system in accordance with SAE J2249 or WC4:2012 section 18 that creates the shoulder and lap belt combination that attaches to the wheelchair or to the floor of the vehicle.
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    K Number
    K120501
    Device Name
    CHAMP CHAMP TRANSIT
    Date Cleared
    2012-09-20

    (212 days)

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

    CONVAID PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Convaid's Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its' intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently nonambulatory and limited to a sitting position. In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vehicle when used in conjunction with an approved fourpoint, strap-type tiedown system per ANSI-RESNA WC-19:2000.
    Device Description
    The Champ CH10 and CH10T are lightweight folding aluminum and steel framed wheelchairs with a seating module that can be used with an optional activity base. It contains the same typical components found on most manual wheelchairs. Champ CH10T transit model is the CH10 model with the addition of transport anchors. The CH10T model has been crash tested to WC- Vol 1 section 19:2000 and approved for use as seating in a motor vehicle.
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    K Number
    K032402
    Device Name
    RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
    Date Cleared
    2003-09-24

    (51 days)

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

    CONVAID PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs. This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions: Amputee; Arthritis: Arthrogriposis; Cerebral Palsy; Geriatric conditions; Head injury or trauma; Hemiplegics; Multiple Scierosis; Muscular Dystrophy; Paraplegic; Polio; Quadriplegic; Spina Bifida; StokeJCVA; Tetraplegic; and Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis
    Device Description
    The Rodeo model is constructed of the same materials and contains the same typical components found on most manual wheelchairs. The frame consists primarily of powder coated round tubular steel from 5/8" to 1" diameter, that is welded, bolted and riveted. With 6" front wheels attached to pivoting casters for steering and turning, and 8" wheels in the rear. The product is a lightweight folding or non-rigid type wheelchair, which is designed for everyday indoor or outdoor use on firm terrain. Also available with a transit option for use in approved transport vehicles. The Rodeo offers its users a 10°-45° of adjustable tilt and 90°-105° of seat to back angle adjustment and comes with a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. Adjustable seat depth, footplate and height of push handle.
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