BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    THERA-Trainer lyra

    DI: 04041925002775 · Model: 01.XX.XX · medica - Medizintechnik GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    THERA-Trainer lyra
    Primary DI
    04041925002775
    Version / Model
    01.XX.XX
    Company Name
    medica - Medizintechnik GmbH
    Labeler DUNS
    328011325
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-23
    Public Version
    1
    Public Version Date
    2023-10-31
    Public Version Status
    New
    Public Device Record Key
    d398ec7d-9b58-4467-bece-c657d7c50de8

    Device Description

    The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    IKK System, Isokinetic Testing And Evaluation

    GMDN Terms

    Code Name
    47516 Treadmill/elliptical gait rehabilitation system

    Identifiers

    Type ID
    Primary 04041925002775