BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioWavePENS

    Reg #: 3004558433 · FEI: 3004558433 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BIOWAVE CORPORATION
    Registration Number
    3004558433
    FEI Number
    3004558433
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 KNIGHT STREET, Suite 201
    City
    NORWALK
    State
    CT
    ZIP
    06851
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061166

    Owner / Operator

    Firm Name
    BIOWAVE CORPORATION
    Operator Number
    9086399
    Address
    8 KNIGHT STREET, Suite 201, --
    City
    Norwalk
    State
    CT
    Postal Code
    06851
    Country
    US
    Correspondent
    Bradford - Siff

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief NHI

    Proprietary Names

    BioWavePENS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device