BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tranquility Pro

    Reg #: 3010358861 · FEI: 3010358861 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Koncept Innovators, LLC
    Registration Number
    3010358861
    FEI Number
    3010358861
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1619 Executive Ave
    City
    Myrtle Beach
    State
    SC
    ZIP
    29577
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201484

    Owner / Operator

    Firm Name
    Koncept Innovators, LLC
    Operator Number
    10059662
    Address
    1619 Executive Ave
    City
    Myrtle Beach
    State
    SC
    Postal Code
    29577
    Country
    US
    Correspondent
    Sylvan Newby

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK
    Device, Jaw Repositioning LQZ

    Proprietary Names

    Tranquility Pro Tranquility Pro 2 Anti-Snoring Mouth Guard TRANQUILITY TRANQUILITY PRO Eliminator Pro 2 Tranquility Anti-Snoring Mouth Guard Somnos Pro 2 Tranquility PRO 2 Anti-Snoring Mouth Guard Bright Guard Pro 2 Tranquility Pro Anti-Snoring Mouth Guard TRANQUILITY PRO 2 Tranquility PRO Tranquility PRO 2 Serenity Pro 2 Intelliguard Pro Tranquility Pro 2 Tranquility Somnos Anti-Snoring Mouth Guard Tranquility PRO Anti-Snoring Mouth Guard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198