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510(k) K151050

Pacifier Activated Lullaby (PAL®) by Power Medical Devices, LLC — Product Code HCC

K151050 is an FDA 510(k) premarket notification submitted by Power Medical Devices, LLC for the device "Pacifier Activated Lullaby (PAL®)". The FDA issued a decision of Substantially Equivalent on December 22, 2015. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
April 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances for product code HCC

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  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources