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510(k) Data Aggregation

    K Number
    K110377
    Device Name
    PROTECTIVE RESTRAINT
    Manufacturer
    MEDI-TECH INTL. CORP.
    Date Cleared
    2011-04-25

    (75 days)

    Product Code
    FMQ, FMO
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.
    Device Description
    The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended for medical purposes to control the movement of a patient's hand or finger movements thereby enabling examination or protection of the patient or others. Device Design Materials Used/Physical Properties: The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers. Primarily comprised of cotton and polyester material and polyester fiber filling.
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    K Number
    K081264
    Device Name
    STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
    Manufacturer
    CHILDREN'S HEALTH FIRST, INC.
    Date Cleared
    2009-02-13

    (284 days)

    Product Code
    FMQ, FPL
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.
    Device Description
    The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.
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    K Number
    K080448
    Device Name
    CENTURION PROTECTIVE RESTRAINT, SCR SERIES
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Date Cleared
    2008-08-28

    (191 days)

    Product Code
    FMQ, FMO
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others. This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting. The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
    Device Description
    The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.
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    K Number
    K013239
    Device Name
    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
    Manufacturer
    MED GEN, INC.
    Date Cleared
    2001-11-20

    (53 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation. ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.
    Device Description
    (a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.
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    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?
    Product Code :

    FMQ

    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?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991591
    Device Name
    BIOTHANE PATIENT RESTRAINT
    Manufacturer
    BIOPLASTICS
    Date Cleared
    1999-07-29

    (83 days)

    Product Code
    FMQ, FMO
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
    Device Description
    Not Found
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    K Number
    K982178
    Device Name
    VAGABOND SOFT RESTRAINT SYSTEM
    Manufacturer
    EMERGENT INNOVATIONS, LTD.
    Date Cleared
    1999-01-26

    (218 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Yagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride. Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport. Vagabond for Panoose Application: The papose application is necessary for the pediatric patients who require emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an and for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed. Yagabond for bed restraint: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.
    Device Description
    Not Found
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    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?
    Product Code :

    FMQ

    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
    K972446
    Device Name
    PEDO CUSH PEDO CUDDLE
    Manufacturer
    CAVITY FREE KIDS, INC.
    Date Cleared
    1997-11-13

    (136 days)

    Product Code
    FMQ, ISM
    Regulation Number
    880.6760
    Why did this record match?
    Product Code :

    FMQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.
    Device Description
    A combination restraint and cushion for securing a pediatric patient in a dental chair, said combination comprising; a restraint comprising a main body portion which has a plurality of flaps attached thereto, each of said flaps having hook and loop fasteners affixed thereto, such that said flaps can be positioned and fastened around said patient to hold said patients torso in position a plurality of strings (straps) for tying said restraint around said dental chair and a headpiece which fits around the top of said dental chair, said restraint having adhesive material affixed to the back thereof to hold said restraint in position on said dental chair, and a cushion having an arcuste indentation at its top end to hold said petient's buttooks in position, said cushion being enclosed in a pillowcase having an adhesive material affixed to the underside thereof in order to maintain said cushion in position on said dental chair, said pillowcase having a plurality of flaps attached thereto, said flaps each having hook and loop fasteners affixed thereto such that said flaps can be positioned and fastened around said patient's legs to hold them in position. Pedo Cush Pedo Cuddle is covered by U.S. Patent N. 5,425, 381 and is described in more detail therein.
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