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510(k) Data Aggregation

    K Number
    K963479
    Device Name
    WHEELCHAIR BELT
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    1997-01-24

    (143 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Industries, Inc. Wheelchair Belt is indicated for use, at the discretion of a responsible licensed healtheare professional, to limit patient movements thereby enabling examination or protection of the DeRoyal Industries, Inc. Wheelchair Belt is intended to be used with a wheelchair only.
    Device Description
    The DeRoyal Industries, Inc. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair. Device Design/Materials Used/Physical Properties: The DeRoyal Wheelchair Belt is designed similar to those marketed by other manufacturers. The Wheelchair Belt is primarily comprised of nylon or polyester seat belt webbing,
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    K Number
    K963475
    Device Name
    PONCHO VEST RESTRAINT
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    1997-01-22

    (141 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
    Device Description
    The DeRoyal Industries, Inc. Poncho Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Poncho Vest Restraint is designed similar to those marketed by other manufacturers. The Poncho Restraint is primarily comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
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    K Number
    K963480
    Device Name
    MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Date Cleared
    1997-01-22

    (141 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enamination or protection of th patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Bod Holder is a protective restraint which can be used with a bed or wheelchair.
    Device Description
    The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intend medical purposes to limit patients thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Multi-Purpose Utility Restraint/ Body Holde designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint Body Holder is prima - comprised of nylon or cotton.
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    K Number
    K963459
    Device Name
    SUPPORT VEST
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-15

    (42 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.
    Device Description
    The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.
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    K Number
    K963461
    Device Name
    SAFETY PONCHO/SHOULDER STRAP PONCHO
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-11

    (38 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.
    Device Description
    Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only. Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.
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    K Number
    K963455
    Device Name
    SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-08

    (35 days)

    Product Code
    KID
    Regulation Number
    890.3910
    Why did this record match?
    Product Code :

    KID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sleeved jacket is intended for patients who require support while seated in a wheelchair. The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair. Both are intended for patients who have a history of removing vest-style and poncho-style restraints.
    Device Description
    Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling. Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.
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