Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K970334
    Device Name
    NATURE'S CRADLE
    Manufacturer
    INFANT ADVANTAGE, INC.
    Date Cleared
    1997-04-25

    (87 days)

    Product Code
    FMS
    Regulation Number
    880.5140
    Why did this record match?
    Product Code :

    FMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nature's Cradle® C2000 Series, when used as directed, is an infant motion and sound system designed to closely simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. This provides a transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. Nature's Cradle C2000 Series can be used with Infant Advantage approved bassinets and hospital nursery tubs or bassinets. Nature's Cradle® C2000 Series is indicated for healthy, full term infants at home or hospital.
    Device Description
    Nature's Cradle® C2000 Series is an infant motion and sound system. It uses a mechanism connected to a control module and a low voltage wall-mount transformer. A mattress is placed on top of a moving platform. A fitted sheet is placed over the top of the bassinet or tub and secured with a cord. The device includes safety checks to stop the mechanism if there is excessive weight or obtrusion. All components are non-sterile and reusable.
    Ask a Question
    K Number
    K963210
    Device Name
    VAIL 100 PEDIATRIC CRIB
    Manufacturer
    VAIL PRODUCTS, INC.
    Date Cleared
    1996-11-13

    (89 days)

    Product Code
    FMS
    Regulation Number
    880.5140
    Why did this record match?
    Product Code :

    FMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960747
    Device Name
    NATURE'S CRADLE MODEL C1500
    Manufacturer
    INFANT ADVANTAGE, INC.
    Date Cleared
    1996-05-22

    (89 days)

    Product Code
    FMS
    Regulation Number
    880.5140
    Why did this record match?
    Product Code :

    FMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nature's Cradle® Model C1500, when used as directed, is designed to provide a safe and effective transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. The mattress is equipped with motion and sound designed to simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. Nature's Cradle Model C1500 is intended to be used for healthy, full term infants at home from 0-16 weeks.
    Device Description
    The Nature's Cradle® Model C1500 is a new device that is based on the same technology and the same indications for use as Nature's Cradle " Infant Bassinet, Model M-1, 510(k) Premarket Notification # K901763. The moving platform is now embedded in the mattress, thus omitting the bassinett. The new mattress fits standard crib size (27 1/2 wide, 51 7/8" long, 4 1/2" high.) The sounds are fed to the mattress through a speaker cable from a control box located outside the mattress. The motions are generated by a low voltage DC (direct current) motor located underneath the platform and connected to a worm drive gear reduction located in the control module. Control module and moving platform are connected with a tube including speaker wire and power supply for the DC motor.
    Ask a Question
    K Number
    K960012
    Device Name
    STRYKER ADEL BASSINET
    Manufacturer
    STRYKER CORP.
    Date Cleared
    1996-03-25

    (83 days)

    Product Code
    FMS
    Regulation Number
    880.5140
    Why did this record match?
    Product Code :

    FMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1