DEVICE: THERA-Trainer toro (04041925005981)

Device Identifier (DI) Information

THERA-Trainer toro
01.YY.XX
In Commercial Distribution

medica - Medizintechnik GmbH
04041925005981
GS1

1
328011325 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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
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FDA Product Code

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Product Code Product Code Name
BXB Exerciser, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5b4e90d8-5760-4591-ad70-fec730c19f49
August 27, 2024
1
August 19, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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