DEVICE: Hand of Hope (04897113220144)
Device Identifier (DI) Information
Hand of Hope
HOH4-BOX SET-W
In Commercial Distribution
Rehab-Robotics Company Limited
HOH4-BOX SET-W
In Commercial Distribution
Rehab-Robotics Company Limited
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
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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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.
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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
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
88262621-8c85-438f-b48f-4f736fe937b7
December 02, 2022
1
November 24, 2022
December 02, 2022
1
November 24, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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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