THERA-Trainer toro

GUDID 04041925005981

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.

medica - Medizintechnik GmbH

Continuous passive motion joint exerciser

• Primary Device ID: 04041925005981
• NIH Device Record Key: 5b4e90d8-5760-4591-ad70-fec730c19f49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERA-Trainer toro
• Version Model Number: 01.YY.XX
• Company DUNS: 328011325
• Company Name: medica - Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041925005981 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-27
• Device Publish Date: 2024-08-19

Devices Manufactured by medica - Medizintechnik GmbH

• 04041925005981 - THERA-Trainer toro: 2024-08-27The 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.
• 04041925005981 - THERA-Trainer toro: 2024-08-27 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
• 04041925006186 - OmniCycle Connect: 2023-11-23 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
• 04041925002706 - THERA-Trainer tigo: 2023-10-31 The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The tr
• 04041925002713 - THERA-Trainer balo: 2023-10-31 THERA-Trainer balo is a standing aid with balance function, suitable for static-dynamic training of patients with limited standi
• 04041925002720 - THERA-Trainer coro: 2023-10-31 THERA-Trainer coro is a standing aid with balance function, suitable for static-dynamic training of patients with limited standi
• 04041925002775 - THERA-Trainer lyra: 2023-10-31 The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. T
• 04041925002812 - THERA-Trainer bemo: 2023-10-31
• 04041925002744 - Thera-trainer Mobi: 2023-10-11 Portable bicycle exerciser