LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193239
    Device Name
    MPowRx Snoring Solution (also known as Good Morning Snore Solution)
    Manufacturer
    MPowRx Health and Wellness Products 2012 Inc
    Date Cleared
    2020-01-03

    (39 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MPowRx™ Snoring Solution (Also known as Good Morning Snore Solution®) is intended as an aid in the reduction of snoring for adults at least 18 years old.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the MPowRx Snoring Solution. While it confirms the device's substantial equivalence to a predicate device and states its intended use, it does not contain any information regarding specific acceptance criteria, device performance metrics, study design, or methodology used to prove the device meets these criteria.

    Therefore, I cannot answer your questions based on the provided input. The document focuses on regulatory clearance, not on a detailed clinical or performance study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1