BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Sofwave System

    Reg #: 3015889734 · FEI: 3015889734 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOFWAVE MEDICAL LTD.
    Registration Number
    3015889734
    FEI Number
    3015889734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HaOtsma 1, POB 157
    City
    Yokneam Illit Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K211483

    Owner / Operator

    Firm Name
    Sofwave Medical Ltd.
    Operator Number
    10061304
    Address
    HaOtsma 1, POB 157
    City
    Yokneam Illit
    State
    IL-NOTA
    Postal Code
    2069203
    Country
    IL
    Correspondent
    Genady Nahshon

    US Agent

    Business Name
    Preferred Depot
    Contact Name
    Isaac Elkah
    Address
    2492 Walnut Avenue, Suite 120
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    844 7702727

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV

    Proprietary Names

    Sofwave System

    Establishment Types

    Manufacture Medical Device