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510(k) Data Aggregation

    K Number
    DEN240031

    Validate with FDA (Live)

    Device Name
    Prapela SVS hospital bassinet pad (model P01)
    Manufacturer
    Prapela, Inc.
    Date Cleared
    2025-04-04

    (291 days)

    Product Code
    QVY
    Regulation Number
    880.5151
    Type
    Direct
    Panel
    General Hospital
    Age Range
    0.71 - 120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Prapela SVS hospital bassinet pad is indicated as adjunctive non-pharmacological therapy in newborns ≥37 weeks gestational age exposed prenatally to opioids with neonatal opioid withdrawal syndrome (NOWS).

    The Prapela SVS hospital bassinet pad is indicated for prescription use only.

    Device Description

    The Prapela Stochastic Vibrotactile Stimulation (SVS) hospital bassinet pad (model P01) is a non-sterile, reusable, mattress pad that has a transducer embedded in the foam of the mattress. The transducer is located in the center of the pad and produces small-input stochastic stimulations that resonate through the foam of the pad. The pad comes with a hand-held control unit that toggles the vibrations on and off. When the vibrations are turned on, the stimulation cycles in 3 hours ON/OFF cycle. The mattress pad is designed to fit most standard hospital grade bassinets.

    AI/ML Overview

    N/A

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