DEVICE: THERA-Trainer tigo (04041925002706)
Device Identifier (DI) Information
THERA-Trainer tigo
02.XX.XX
In Commercial Distribution
medica - Medizintechnik GmbH
02.XX.XX
In Commercial Distribution
medica - Medizintechnik GmbH
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 two drive units which differentiate in upper and lower extremities. The drive unit for lower extremities is limited in extent by the selected crank radius. The drive unit for upper extremities is limited to one crank radius. Both drive units are never moved simultaneously. The therapy drive units for leg and arm do drive a supportive accessory for legs (footrests) and arms (therapy grips, arm support or arm rest) in a circular motion. The different accessories are interchangeable by the operator. With the user interface the operator is able to select a training type (upper extremity or lower extremity training) which heads for related therapy drive unit. The medical device guarantees 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 and transport belt. The interfaces of the upper drive unit are designed in such a way that other accessory options are easy to attach. The requirements for the use of these accessories are derived from the degree of disability of the user. The training of the upper extremities should be possible as an option and does not have to be present as a matter of principle.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BXB | Exerciser, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b18e6cf8-d8fe-411d-99cc-9ff837039d7e
October 31, 2023
1
October 23, 2023
October 31, 2023
1
October 23, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined