BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HAL for Medical Use

    DI: 04560340091091 · Model: HAL-ML05-DXWUS · CYBERDYNE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HAL for Medical Use
    Primary DI
    04560340091091
    Version / Model
    HAL-ML05-DXWUS
    Company Name
    CYBERDYNE, INC.
    Labeler DUNS
    714480766
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-01
    Public Version
    2
    Public Version Date
    2022-05-11
    Public Version Status
    Update
    Public Device Record Key
    49ebb48f-249d-41ab-bbdc-26d84e7cf5be

    Device Description

    Number of legs: Double Leg length: eXtra long Hip width: Wide

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HCC Device, Biofeedback
    PHL Powered Exoskeleton

    GMDN Terms

    Code Name
    63288 Neuro-controlled ambulation exoskeleton

    Identifiers

    Type ID
    Primary 04560340091091