DEVICE: THERA-Trainer coro (04041925002720)
Device Identifier (DI) Information
THERA-Trainer coro
02.XX.XX
In Commercial Distribution
medica - Medizintechnik GmbH
02.XX.XX
In Commercial Distribution
medica - Medizintechnik GmbH
THERA-Trainer coro is a standing aid with balance function, suitable for static-dynamic training of patients with limited standing capacity. Safe standing and balance are important requirements for walking. THERA-Trainer coro offers patients a safe environment during training based on a stable frame that supports the patient at the hips and optionally at the knees to practice standing and balancing without any danger and fear of falling. A mechanical adjustment function makes it possible to switch from static to dynamic standing training. In dynamic, balancing training the frame relies on a set of springs that offer a dynamic resistance to upper body movement while still ensuring a safe environment preventing falls.
Device Characteristics
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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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13964 | Physical therapy table, non-powered |
A dedicated device specifically designed for use in physical therapies. It is a non-powered device that has manually-adjustable table top functions for height and position, including vertical tilting from supine to upright. It will typically incorporate foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). This device is designed for treatment of diseases using therapeutic exercises and massage, e.g., to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury) and also to aid in muscle training and sense of balance.
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FDA Product Code
[?]Product Code | Product Code Name |
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PKS | Exerciser, Non-Measuring For Stroke Rehabilitation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
946d19c8-f586-4722-bb1d-64bf8f6af664
October 31, 2023
1
October 23, 2023
October 31, 2023
1
October 23, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined