FDA-Device2015-12-16Class II
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
Powers Medical Devices, LLC
Hazard
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
Sold states
Nationwide Distribution.
Affected count
Total of 128 units
Manufactured in
1615 S Congress Ave Ste 103, N/A, Delray Beach, FL, United States
Products
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0395-2016Don't want to check this manually?
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