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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    CAVITY FREE KIDS, INC.

    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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