DEVICE: Neurolutions Ipsihand Upper Extremity Rehabilitation System (00850005539025)
Device Identifier (DI) Information
Neurolutions Ipsihand Upper Extremity Rehabilitation System
FGS-1000-02
In Commercial Distribution
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution
Neurolutions, Inc
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the 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.
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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64759 | Neuro-controlled joint movement exoskeleton |
An electrically-powered, bionic, orthosis system designed to assist a patient with a limb joint movement disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. The system includes an exoskeleton structure made of metal with electric motors and mechanical actuators; it is typically strapped to a limb around a joint (e.g., ankle, knee, shoulder) over clothing and may be used in a pre-programmed configuration. It is intended for multiple-patient use in a controlled clinical setting (e.g., gait lab, rehabilitation centre).
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FDA Product Code
[?]Product Code | Product Code Name |
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QOL | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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DEN200046 | 000 |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
b148a5e7-10e4-4ff6-9ab2-be324ebd7378
September 20, 2022
1
September 12, 2022
September 20, 2022
1
September 12, 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