Pacifier Activated Lullaby (PAL®)

FDA 510(k) K151050 · Power Medical Devices, LLC

Substantially Equivalent

510(k) numberK151050

Submission

Device name
Pacifier Activated Lullaby (PAL®)
Applicant
Power Medical Devices, LLC
Delray Beach, FL, US
Received
April 20, 2015
Decision date
December 22, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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K143507NFANT Feeding SolutionHCC · Traditional Nfant Labs, LLC09/09/2015SE
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K122879EEGER4 Model 4.3HCC · Traditional Eeg Software, LLC02/06/2013SE
K111687Emg SystemHCC · Special Myotronics-Noromed, Inc.09/29/2011SE
K092675GrindcareHCC · Traditional Medotech A/S03/03/2010SE
K073557EEG Neuroamp, Model CS10137HCC · Traditional Corscience GmbH & Co. KG02/28/2008SE

Questions and answers

When was Pacifier Activated Lullaby (PAL®) cleared by the FDA?

Pacifier Activated Lullaby (PAL®) (K151050) received a 510(k) decision of Substantially Equivalent on December 22, 2015, 246 days after the submission was received.

What is the product code of K151050?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.