BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Medical HAL Lower Limb Type

    Reg #: 3014209670 · FEI: 3014209670 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    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
    K233695

    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
    Powered Exoskeleton PHL
    Device, Biofeedback HCC

    Proprietary Names

    Medical HAL Lower Limb Type

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198