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510(k) Data Aggregation
K Number
K970334Device Name
NATURE'S CRADLE
Manufacturer
INFANT ADVANTAGE, INC.
Date Cleared
1997-04-25
(87 days)
Product Code
FMS
Regulation Number
880.5140Why did this record match?
Applicant Name (Manufacturer) :
INFANT ADVANTAGE, INC.
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.
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K Number
K960747Device Name
NATURE'S CRADLE MODEL C1500
Manufacturer
INFANT ADVANTAGE, INC.
Date Cleared
1996-05-22
(89 days)
Product Code
FMS
Regulation Number
880.5140Why did this record match?
Applicant Name (Manufacturer) :
INFANT ADVANTAGE, INC.
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.
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