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510(k) Data Aggregation
K Number
DEN200046Device Name
Neurolutions Upper Extremity Rehabilitation System
Manufacturer
Date Cleared
2021-04-23
(274 days)
Product Code
Regulation Number
890.5420Why did this record match?
Applicant Name (Manufacturer) :
Neurolutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
Device Description
The Neurolutions IpsiHand Upper Extremity Rehabilitation System (a.k.a. Neurolutions System or IpsiHand System) detects goal-oriented brain activity using non-invasive EEG electrodes to allow a stroke patient to perform therapeutic exercises that they would otherwise not be able to perform, due to their impairment. The Neurolutions System consists of the Neurolutions Handpiece, a Tablet computer, and a Biometric Headset. Using a standard Windows Tablet as the patient interface, the System translates brain signals from the Biometric Headset into movement of the motor-driven Handpiece worn over the patient's hand and wrist. The motion of the Handpiece, in turn, opens and closes the patient's impaired hand. The combined action of these System components allows the stroke patient to perform physical therapy exercises that they would otherwise not be able to perform, due to their impairment. The Biometric Headset, which contains dry electroencephalographic (EEG) sensors, receives electrical signals from the motor or pre-motor cortex, predominantly of the unaffected hemisphere of the patient's brain, and in doing so, detects the patient's intentions to move their affected hand. These intentions to move are translated into motor movements of the Handpiece using software that drives a linear actuator contained inside of the Handpiece. The Handpiece opens and closes the hand using a 3-finger pincer grip mechanism designed to emulate the movement of grasping an object using the two forefingers and thumb in a grasping motion (one degree of freedom). The device functions as powered exercise equipment for the patient's hand using three separate modes: the main mode of therapy is referred to as the brain-computer interface (BCI) or 'thought' mode in which the patient's hand is opened or closed by the powered orthosis based on brain signals received from the Biometric headset; the second mode is referred to as a 'volitional' mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient's hand passively through a comfortable range of motion in a repetitive fashion. The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy.
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