DEVICE: THERA-Trainer toro (04041925006261)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
THERA-Trainer toro
01.05.ZZ
In Commercial Distribution
medica - Medizintechnik GmbH
01.05.ZZ
In Commercial Distribution
medica - Medizintechnik GmbH
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.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| BXB | Exerciser, Powered |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
545095d4-d267-4396-affe-3eb25090fdcb
December 24, 2025
1
December 16, 2025
December 24, 2025
1
December 16, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined