Attached to each side of a thin mat and wedges to elevate the baby s head.
Fda approved crib wedge.
The agency is not aware of any scientific studies showing that a medical device prevents or.
If you have questions about what to do in order to seek fda approval or clearance for your medical device contact cdrh division of industry and consumer education dice at 1 800 638 2041 or via.
Fda cautions against baby.
It is inclined at an angle of 14o and so your child is sure to sleep sound without the problem of continually spitting up.
Jolayle baby crib wedge for reflux baby wedge sleep positioner while other sleep positioners are mostly produced to improve sleep only jolayle baby wedge is mainly built on ending the problem of reflux in infants.
To date the fda has not cleared or approved a baby product to prevent or reduce the risk of sids.