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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome
Definition Reusable hospital mattress pad with integrated mechanical vibrations to be used as adjunctive therapy for neonates and infants with neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS).
Product CodeQVY
Regulation Number 880.5151
Device Class 2


Premarket Reviews
ManufacturerDecision
PRAPELA, INC.
  GRANTED 1

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