BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HAL for Medical Use Lower Limb Type

    Reg #: 3014209670 · FEI: 3014209670 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CYBERDYNE INC.
    Registration Number
    3014209670
    FEI Number
    3014209670
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-2-1 Gakuen-minami
    City
    Tsukuba Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K201559

    Owner / Operator

    Firm Name
    CYBERDYNE Inc.
    Operator Number
    10056809
    Address
    2-2-1 Gakuen-minami
    City
    Tsukuba
    State
    Ibaraki
    Postal Code
    305-0818
    Country
    JP
    Correspondent
    Yohei Suzuki

    US Agent

    Business Name
    CYBERDYNE USA INC.
    Contact Name
    Hiroki Kimura
    Address
    4660 La Jolla Village Drive Suites 100 & 200, Office #234
    City
    San Diego
    State
    CA
    ZIP
    92122
    Country
    US
    Email
    [email protected]
    Phone
    888 5896216

    Products

    Device Name Product Code
    Device, Biofeedback HCC
    Powered Exoskeleton PHL

    Proprietary Names

    HAL for Medical Use Lower Limb Type

    Establishment Types

    Manufacture Medical Device