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510(k) Data Aggregation

    K Number
    K010818
    Device Name
    INFANT LIMB HOLDER, MODELS 306080 & 306081
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    2001-05-24

    (66 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010644
    Device Name
    CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    2001-05-18

    (74 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963458
    Device Name
    PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-18

    (45 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes. Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping. Finger-Separator Padded Mitts have finger channels that help to control hand contracture.
    Device Description
    Padded Mitts are constructed from woven polyester that encloses a 3/4-inch-thick foam palm pad. A top piece of polyester mesh is sewn on the mitts to prevent heat build-up. The mitts have a 1 1/4-inch-wide polyester wrist strap that secures by means of a metal buckle. The underside of the mitt cuff has a loop through which a 44-inch-long looped strap passes. This strap is used to secure the patient's hand/arm range of motion. The outer edges are finished with a bias cut binding. All straps are made of polyester webbing. Padded-Plus Mitts are identical to the above except that the foam used for the palm pad is two-inches-thick. Finger Separator Padded Mitts are identical to Padded-Plus Mitts except that the polyester mesh top piece is stitched to the polyester woven fabric in a such a way as to form finger channels. Rigid-Palm Padded Mitts are identical to the Padded Mitts except that they have a pocket on the bottom side which contains a 6mm pvc insert. This rigid insert, which removes for laundering, is used for patients who require an additional barrier to prevent against grasping at feeding and naso-gastric tubes.
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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?
    Applicant Name (Manufacturer) :

    SKIL-CARE CORP.

    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?
    Applicant Name (Manufacturer) :

    SKIL-CARE CORP.

    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
    K963457
    Device Name
    SLEEPER JACKET/HOUDINI SAFETY SLEEPER
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-09

    (36 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints. The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.
    Device Description
    Sleeper Jacket: A polyester upper body, jacket-style garment. It has short sleeves, a brass back zipper, 1 1/8-inch-wide- polyester webbing ties sewn across the waist. Each webbing end is terminated with a metal clip that secures to the bed frame. The webbing criss-crosses in front of the patient to allow him/her to roll from side to side while sleeping in bed. The edges of the garment are finished with bias cut binding in a color that corresponds to the garment size as described on package insert. The device has instructions that show how it can be applied in both the bed and the wheelchair. Houdini Safety Sleeper: Has the same features as the Sleeper Jacket with the addition of a 1 1/2-inch-wide strap sewn to the back of the garment. The strap is brought between the patient's legs and secured in front of the garment. The purpose of this strap is to prevent the patient from sliding down in the bed or wheelchair.
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    K Number
    K963460
    Device Name
    ROLL BELT
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-09

    (36 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Roll Belt is intended for the patient who requires a safety belt while in bed and who requires a reminder not to leave the bed without assistance.
    Device Description
    The Roll Belt has a cotton duck pad approximately 26 1/2 inches in length. At its narrowest end, the pad is approximately 6 1/2 inches wide, and at its widest end it is approximately eight inches wide. A 1 1/2-inch-wide, 88-inch-long strap made of polyester webbing is stitched to each end of the cotton duck pad. The wide end has a slot that is approximately 6 1/2 inches long and 1 1/2 inches wide. The webbing from the narrow end is inserted through the slot on the wide end, thereby closing the belt while it encircles the patient's waist. The straps criss-cross in front of the patient permitting him/her to roll from side to side. Both straps are secured to the bed frame. The edges of the device are finished with a bias cut binding.
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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?
    Applicant Name (Manufacturer) :

    SKIL-CARE CORP.

    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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    K Number
    K963456
    Device Name
    LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-08

    (35 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reusable Limb Holders, Disposable Limb Holders, and Quik Cuff Limb Holders are intended for patients who require limitations placed on their hand and leg movement.
    Device Description
    Disposable Limb Holder (Synthetic Sheepskin-Double Tie): These limb holders have a 2 1/2-inch-wide by 12-inch-long synthetic cuff to which is sewn a 19-inch-long wrist strap. The wrist strap is 1 1/8-inch-wide polyester webbing. It is terminated with a 1 1/4-inch-wide metal buckle. Approximately 2 1/2 inches back from the buckle a 102inch-long strap (doubled to form two 51-inch-long sections) is sewn to the wrist band. Just beyond the point where this strap is attached, a one-inch-wide, seven-inch-long strip of Velcro loop material is sewn to the cuff. A 2 1/2-inch-long Velcro hook tab is stitched to the same end of the cuff as the buckle. The Velcro hook and loop position the cuff on the wrist or ankle, the wrist strap and buckle secure the device. Sold in pairs. Disposable Limb Holders (Synthetic Sheepskin-Single Tie): Identical to the above except that they have a single 51-inch-long strap sewn to the wrist strap. Disposable Limb Holders (Foam-Double Tie): Identical in construction to the Disposable Limb Holders (Synthetic Sheepskin-Double Tie) except that the cuff is made from 1/4-inch-thick polyurethane foam back with Velcro loop material. Disposable Limb Holders (Foam-Single Tie): Identical to above except that they have a single 51-inch-long strap sewn to the wrist strap. Reusable Synthetic Sheepskin Limb Holders: These limb holders have a 2 1/2-inchwide, 12-inch-long synthetic sheepskin cuff to which is sewn a 19-inch-long, 1 1/8inch-wide polyester wrist strap. The wrist strap is terminated with a metal buckle. A polyester strap of 1 1/8 inches in width is stitched to the wrist band approximately 2 1/2 inches beyond the buckle. This strap is 102-inches-long and is doubled to form two 51-inch-long sections. Quik-Cuff Limb Holders: These have a 2 1/2-inch-wide, 12-inch-long synthetic sheepskin cuff to which is attached a 19-inch-long, one-inch-wide Velcro backstrap that includes a one-inch-wide Delrin d-ring through which the Velcro is secured. A single, 51-inch long strap is stitched to the cuff and the backstrap approximately at the center of the cuff.
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    K Number
    K963447
    Device Name
    DOUBLE SUPPORT PONCHO/SLIDER PONCHO
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-07

    (34 days)

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

    SKIL-CARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Support Poncho is used for restraint and to provide upper body posture support. The Slider Poncho provides restraint, posture support, and slider control.
    Device Description
    Double Support Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A chest strap is used to provide upper body posture support. A waist strap secures the device the device to wheelchair kickspurs. All straps are 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. Device is intended for wheelchair use only. Slider Poncho: The Slider Poncho has the same configuration as the above 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 and 1 1/8 inch strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the wheelchair cross brace to prevent the patient from sliding down.
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