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510(k) Data Aggregation

    K Number
    K980640
    Device Name
    HEELBO WAIST AND CHEST VEST
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1998-05-01

    (71 days)

    Product Code
    FMQ, FMO
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.
    Device Description
    The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B).
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    K Number
    K963372
    Device Name
    HEELBO ER WRIST RESTRAINT
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-11-07

    (72 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or elevated positions.
    Device Description
    The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient's wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots. The Heelbo ER Wrist Restraint are machine washable.
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    K Number
    K963060
    Device Name
    HEELBO SECURITY BELT
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-11-04

    (89 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
    Device Description
    The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
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    K Number
    K963099
    Device Name
    HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-11-01

    (84 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.
    Device Description
    The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in. Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.
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    K Number
    K963041
    Device Name
    HEELBO LIFE JACKET WITH CROTCH SUPPORT
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-31

    (87 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
    Device Description
    The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B).
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    K Number
    K962831
    Device Name
    THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-18

    (88 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions
    Device Description
    The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.
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    K Number
    K962832
    Device Name
    HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-18

    (88 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heelbo Quilted Limb Holder with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
    Device Description
    Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair, gerichair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The adjustable Double D-Ring allows for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable. The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long Stock No. 9330 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
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    K Number
    K962834
    Device Name
    HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-18

    (88 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
    Device Description
    Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes: Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
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    K Number
    K962839
    Device Name
    HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-18

    (88 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heelbo Quilted Limb Holder with Buckle and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
    Device Description
    The Heelbo Quilted Limb Holder with Buckle and Strap is a quilted limb holder with a Velcro® fastener, buckle and straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Buckle and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The adjustable buckle allows for supine and sitting positions. The Heelbo Quilted Limb Holder is machine washable.
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    K Number
    K963294
    Device Name
    HEELBO WRAP AROUND VEST
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-11

    (51 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEELBO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
    Device Description
    The Heelbo Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails. The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots. The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.
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