AccessGUDID - DEVICE: Neurolutions Ipsihand Upper Extremity Rehabilitation System (00850005539018)

GUDID

Device Identifier (DI) Information

Brand Name: Neurolutions Ipsihand Upper Extremity Rehabilitation System
Version or Model: FGS-1000-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neurolutions, Inc

Primary DI Number: 00850005539018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067760283 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOL	Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200046	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 088a7ee7-4ef1-48ed-9094-9d771a3fce9d
Public Version Date: September 20, 2022
Public Version Number: 1
DI Record Publish Date: September 12, 2022