BEUDAMED
    FDA Registration Active 🇺🇸 United States

    H200 Wireless System

    Reg #: 3036471706 · FEI: 3036471706 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIONESS MEDICAL, INC.
    Registration Number
    3036471706
    FEI Number
    3036471706
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25103 Rye Cyn Loop
    City
    Valencia
    State
    CA
    ZIP
    91355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111767

    Owner / Operator

    Firm Name
    Bioness Medical, Inc.
    Operator Number
    10092201
    Address
    25103 Rye Cyn Loop
    City
    Valencia
    State
    CA
    Postal Code
    91355
    Country
    US
    Correspondent
    Michael Lopez

    Products

    Device Name Product Code
    Stimulator, Neuromuscular, External Functional GZI

    Proprietary Names

    H200 Wireless System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device