THERA-Trainer toro

Basic Information

• Brand Name: THERA-Trainer toro
• Primary DI: 04041925006193
• Version / Model: 01.YY.XX
• Company Name: medica - Medizintechnik GmbH
• Labeler DUNS: 328011325
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-04
• Public Version: 2
• Public Version Date: 2025-12-17
• Public Version Status: Update
• Public Device Record Key: 6ad5373e-4c3d-425c-a28d-4e684272b764
• Distribution End Date: 2025-12-16

Device Description

The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The system is used in a seated position, e.g. in a wheelchair or suitable therapy chair. The movement is managed by the therapy drive unit and is limited in extent by the selected crank radius. The upper and lower extremities are driven by the same drive unit. The extremity arms and legs are never moved simultaneously by the therapy drive unit. The therapy drive unit drives a support device for legs (footrest) and arms (therapy grips) in a circular motion. The different positioning devices should be easily interchangeable by the operator. With the base frame and the electronic pivoting therapy drive unit, the therapy drive unit can be positioned individually in front of the user. Suitable devices guarantee a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The device can be easily transported to different places of use or storage by means of castors. The interfaces of the arm/leg accessory are designated in such a way that options from the current CL product portfolio can be used. This is intended to provide optimum protection for the user. The requirements are derived from the degree of disability of the user. Especially in clinics the point hygiene is very important, so an easy disinfection and cleaning is possible.

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	Medical Specialty	Regulation #	Device Class
BXB	Exerciser, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36313	Continuous passive motion joint exerciser	A mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04041925006193	GS1