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510(k) Data Aggregation

    K Number
    K251570
    Device Name
    Hippocampe Marathon and Trail
    Manufacturer
    Date Cleared
    2025-06-23

    (32 days)

    Product Code
    Regulation Number
    890.3880
    Why did this record match?
    Product Code :

    IQC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hippocampe Marathon and Trail is indicated to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails.
    Device Description
    The Hippocampe Marathon and Trail is an occupant or care provider propelled manual operated wheelchair. The Hippocampe Marathon and Trail is designed for everyday use as well as recreational activity such as running and trail running, in the following environments: - Indoors and outdoors; - Over smooth, rough, and uneven ground; - Over soft and hard surfaces; - Over small obstacles, like door jams; and - Up, down and across slopes. The Hippocampe Marathon and Trail is a three-wheel triangular wheelchair comprised of bent aluminum tubing frame that are bent, joined, fastened, and/or coupled with connectors to form a frame. The frame consists primarily of a lower frame, adjustable height seat back frame, adjustable headrest, push bar and push bar frame, tubing clamp connectors, footrest, arm rests, rear axle assembly, and front fork and axle assembly. Once assembled, the wheelchair frame is fixed. The recline of the seat back frame can be adjusted with depth adjustment screws at the base of the seat back frame. The upholstery is attached to the frame using nylon straps and buckles and is fire resistant. A rigid plastic open basket-like structure located in the middle of the lower frame and behind the front fork assembled provides the occupant a footrest and has a removable layer of foam. On the push bar are control levers for disc brakes of the rear wheels which are operated by the occupant's care provider. The disc brakes also act as parking brakes and are activated by the care provider. The Hippocampe Marathon and Trail can be easily assembled and disassembled for stowage or storage by detaching the lower frame of the armrest and folding the seat back frame forwards. The wheelchair is available in three sizes: medium, large and extra-large. The maximum weight capacity of Hippocampe Marathon and Trail is 220 lbs.
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    K Number
    K120302
    Device Name
    MECHANICAL WHEELCHAIR
    Date Cleared
    2012-07-06

    (156 days)

    Product Code
    Regulation Number
    890.3880
    Why did this record match?
    Product Code :

    IQC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
    Device Description
    The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it. This is a very long life product with the following components: Wheelchair, Foldable armrests, Foldable footrest, Starring/traction bar. The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg. All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects. Users manual provides information on warnings, cautions, maintenance and operation instructions.
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    K Number
    K082857
    Device Name
    RENEGADE WHEELCHAIR
    Manufacturer
    Date Cleared
    2009-01-06

    (99 days)

    Product Code
    Regulation Number
    890.3880
    Why did this record match?
    Product Code :

    IQC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.
    Device Description
    The Renegade is designed to offer the user the option of conventional hand-to-wheel propulsion, or the use of pushbar levers which provide thrust by way of a gear and chain system. Each wheel has multiple gears and independent brakes, providing versatility and control. The wheelchair is fitted with accessory holders to provide a means to carry sports and recreational equipment.
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    K Number
    K051709
    Device Name
    HIPPOCAMPE WHEELCHAIR
    Date Cleared
    2005-08-15

    (49 days)

    Product Code
    Regulation Number
    890.3880
    Why did this record match?
    Product Code :

    IQC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
    Device Description
    The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components. - Wheel chair t - Pushbar . - Trunk harness (optional) . - Armrest (optional) . - Headrest (optional) . - . Skiing kit (optional) - . Traction kit - Transport bag (optional) . The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.
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