BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SOFWAVE MEDICAL LTD.

    Reg #: 3015889734 · FEI: 3015889734 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SOFWAVE MEDICAL LTD.
    Registration Number
    3015889734
    FEI Number
    3015889734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HaOtsma 1, POB 157
    City
    Yokneam Illit Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K230019

    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
    Erez Panir

    US Agent

    Business Name
    Preferred Depot
    Contact Name
    Isaac Elkah
    Address
    39 Parker
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    844 7702727

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    Sofwave Pure Impact VIP SofWave Sofwave System

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility