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Hand of Hope

Rehab-Robotics Company Limited · Model HOH4-PSM-LR-W · UDI-DI 04897113220052

BXB Prescription
10
510(k) clearances
150
Adverse events
6
Recalls
116
Facilities

Description

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

Recalls

DateFirmReason
2024-08-01Btt Health GmbhSome power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical devic
2019-07-29MOTEK MEDICAL B.V.The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable gu
2013-06-12Accelerated Care Plus CorporationAn anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
2012-11-12BioMotion Medical Systems, LLCBioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involvin
2011-07-15Alter-G, IncorporatedPotential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
2009-05-27Hocoma AGChanges to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.