BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Jewel® Patch Wearable Cardioverter Defibrillator ("Jewel")

    Reg #: 3027605722 · FEI: 3027605722 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ELEMENT SCIENCE, INC.
    Registration Number
    3027605722
    FEI Number
    3027605722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    301 Chesapeake Dr
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    PMA Number
    P230022

    Owner / Operator

    Firm Name
    Element Science, Inc.
    Operator Number
    10093342
    Address
    301 Chesapeake Drive
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    John Kang

    Products

    Device Name Product Code
    Wearable Automated External Defibrillator MVK

    Proprietary Names

    Jewel® Patch Wearable Cardioverter Defibrillator ("Jewel")

    Establishment Types

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