DEVICE: Hand of Hope (04897113220038)

Device Identifier (DI) Information

Hand of Hope
HOH4-SML-LR-W
In Commercial Distribution

Rehab-Robotics Company Limited
04897113220038
GS1

1
663460271 *Terms of Use
The Hand of Hope (HOH) is a therapy device (exoskeleton) used for neuromuscular rehabilitation of the hand and forearm. HOHfunctions as a biofeedback device where surface electromyography (sEMG) electrodes depict voluntary muscle activation. Thedepicted signals are processed and simplified, and can be seen by a convenient presentation of visual feedback. The sEMGreadout enables patients to monitor the fundamental neuromuscular functional state. Therefore, impairment, functional limitationand impaired volitional movement due to stroke or other neurologic or orthopaedic diseases can be easily presented and utilizedby a sensory signal. Patient’s attention is drawn to the task through a visually displayed sEMG signal and consequently used forthe initiation of the motor task. This biofeedback mechanism promotes motor learning via interactive use. In particular, stroke isone of the leading causes of adult disability, and hand rehabilitation after stroke is a very challenging part thereof. However, it iswell known that sensory signals such as visual sensory inputs reach the motor cortex and modulate motor cortex function andexcitability, and therefore can improve motor learning. Since active participation and initiation of the movement is the key tosuccess, using the biofeedback system, HOH motivates patients to actively interact with the system during an sEMG controlledtask-related training regime
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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?
47517 Virtual-display rehabilitation system, powered-support, upper-limb
An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software.
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

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Premarket Submission Number Not Available/Not Released
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Sterilization

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No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9098c6f8-fc6a-4574-b641-047fc6742baf
December 02, 2022
1
November 24, 2022
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Alternative and Additional Identifiers Additional Identifiers

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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