BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    MyoWorx TM20

    Reg #: 3014377577 · FEI: 3014377577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MYOWORX, INC.
    Registration Number
    3014377577
    FEI Number
    3014377577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    77 Westmount Road, Suite 201
    City
    Guelph Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K192746

    Owner / Operator

    Firm Name
    MyoWorx, Inc.
    Operator Number
    10059881
    Address
    77 Westmount Road, Suite 201
    City
    Guelph
    State
    Ontario
    Postal Code
    N1H 5J1
    Country
    CA
    Correspondent
    Bert Oucharek

    US Agent

    Business Name
    DP Distribution & Consulting
    Contact Name
    Darren Reeves
    Address
    12240 Hunting Horn Lane
    City
    Rockville
    State
    VA
    ZIP
    23146
    Country
    US
    Email
    [email protected]
    Phone
    804 3077706

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    MyoWorx TM20

    Establishment Types

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