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    FDA UDI In Commercial Distribution 🇺🇸 United States

    THERA-Trainer toro

    DI: 04041925006254 · Model: 01.05.ZZ · medica - Medizintechnik GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    THERA-Trainer toro
    Primary DI
    04041925006254
    Version / Model
    01.05.ZZ
    Company Name
    medica - Medizintechnik GmbH
    Labeler DUNS
    328011325
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-16
    Public Version
    1
    Public Version Date
    2025-12-24
    Public Version Status
    New
    Public Device Record Key
    24d5cc92-6a58-4921-97c0-3279ac393aca

    Device Description

    General description: The system is a therapeutic device for circular passive, assistive or active movement. The transition from motor-supported passive to active therapy is seamless. The medical device can be used in a sitting position and the pivoting drive makes it easy to switch from lower extremity to upper extremity mode. The system can be used stationary or wheeled from room to room effortlessly. With the barrier free base frame and using the pivoting drive unit, the device can be individually positioned for each patient. The device can be quickly adapted to the patient through tool-free adjustments and various accessories. The software offers goal-oriented gamification, assessments and documentation to track therapy progress. The encased crank design ensures effective disinfection and safety. The system therefore facilitates safe, easy and efficient therapy for active persons as well as weak patients with particular needs. The equipment at the device ensure a stable, non-slip, and tilt-resistant position both during preparation and throughout the training session. Suitable devices guarantee a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The therapy drive unit moves the support devices for the legs (footrests) and arms (e.g. therapy grips) in a circular motion. The patient’s movement is controlled by the therapy drive unit and limited by the selected crank radius. Both the upper and lower extremities are trained by the same drive unit. The therapy drive unit never moves the arms and legs simultaneously. The interfaces for the arm and leg accessories are designed for easy attachment and exchange of specific options. This allows optimal securing of the patient according to their individual needs and degree of impairment. Additional description: THERA-Trainer toro with electrical height adjustment and mobility chassis.

    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
    BXB Exerciser, Powered

    GMDN Terms

    Code Name
    36313 Continuous passive motion joint exerciser

    Identifiers

    Type ID
    Primary 04041925006254