BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    JH DW4AT Tuned hearing Aids

    Reg #: 3023339161 · FEI: 3023339161 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TUNED LTD
    Registration Number
    3023339161
    FEI Number
    3023339161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Harimon
    City
    Gan Yoshiya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K223848

    Owner / Operator

    Firm Name
    Tuned LTD
    Operator Number
    10085651
    Address
    Harimon
    City
    Gan Yoshiya
    State
    Central
    Postal Code
    38850
    Country
    IL
    Correspondent
    Omri Gavish

    US Agent

    Business Name
    ProMedoss
    Contact Name
    Shoshana Friedman
    Address
    3521 Hatwynn Rd.
    City
    Charlottee
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    704 4308695

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    JH DW4AT Tuned hearing Aids Tuned Lumen® 155 Hearing Aids JVC Tuned Hearing aids JVC EH-Z2000 Intrisound Tuned Lumen® 155 Hearing Aids

    Establishment Types

    Manufacture Medical Device