DEVICE: rebless (Model: RHDB) (08800101600183)
Device Identifier (DI) Information
rebless (Model: RHDB)
RHDB
In Commercial Distribution
1
H ROBOTICS INC.
RHDB
In Commercial Distribution
1
H ROBOTICS INC.
rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use.
rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device.
rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions.
Key features:
1) Isokinetic:
The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury.
2) Adjustable resistance:
The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
3) Adjustable assistance:
The device provides a wide range of adjustable assistance settings, to apply assistance level based on
their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
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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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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FDA Product Code
[?]Product Code | Product Code Name |
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IKK | System, Isokinetic Testing And Evaluation |
FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
c6660a7e-2667-4bca-8d3e-adc26654ef67
November 07, 2023
1
October 30, 2023
November 07, 2023
1
October 30, 2023
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined