Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K161425
    Device Name
    APEX Manual Wheelchair
    Manufacturer
    Motion Composites
    Date Cleared
    2016-12-05

    (196 days)

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

    Motion Composites

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.
    Device Description
    The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The Apex wheelchairs are traditional rigid wheelchairs. They are made of aluminum alloy or carbon fiber. The frame which utilizes a standard geometry that creates a cantilever like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the carbon fiber camber tube via stainless steel axles. On the front end of the frame are assembled two aluminum caster mount. Caster forks are mounted to these mounts via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.
    Ask a Question
    K Number
    K143101
    Device Name
    Helio A7 Manual Wheelchair, Move Manual Wheelchair
    Manufacturer
    MOTION COMPOSITES
    Date Cleared
    2015-05-01

    (184 days)

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

    MOTION COMPOSITES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the Helio A7 and Move Manual Wheelchairs is to provide mobility to persons limited to a sitting position.
    Device Description
    The Motion Composites Helio A7 and Move Manual Wheelchairs are manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. Both are traditional folding cross-brace wheelchairs. They are made of an aluminum frame which utilizes one cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two aluminum caster housings. Caster forks are mounted to these housings via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.
    Ask a Question
    K Number
    K120628
    Device Name
    HELIO
    Manufacturer
    MOTION COMPOSITES
    Date Cleared
    2012-12-19

    (293 days)

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

    MOTION COMPOSITES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The helio wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
    Device Description
    The helio is a traditional folding cross-brace wheelchair. It is made of lightweight hi-Modulus carbon fiber mixed with epoxy resin similar to what is used on existing products such as K915533. The frame utilizes one patented cross brace system that, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum caster housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 back tubes are inserted to the desired height. Backrest upholstery is affixed to the back tubes. Armrests receivers bolt onto the rear of each side frame. Individual swing away armrests are then inserted into the receivers. If flip back armrests are chosen, a receiver is mounted onto the front of each side frame to catch the forward most section of the arm and the rear mounting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Footrests with footplates attach at the front of the chair. There is a plug at the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is inserted 90 degrees away from the frame and rotates inwards. The latch will engage once the footrest hanger is centered.
    Ask a Question

    Page 1 of 1