Neurolutions Ipsihand Upper Extremity Rehabilitation System

Primary DI
00850005539018
Brand
Neurolutions Ipsihand Upper Extremity Rehabilitation System
Company
Neurolutions, Inc
Model
FGS-1000-01
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.
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered ExerciserNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200046000Neurolutions Upper Extremity Rehabilitation SystemNeurolutions, Inc.2021-04-23QOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005539018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005539018008500055390188500055390180850005539018

GMDN Terms#

Term, Definition table
TermDefinition
Neuro-controlled joint movement exoskeletonAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067760283
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005539025Neurolutions Ipsihand Upper Extremity Rehabilitation SystemFGS-1000-022022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005539025Neurolutions Ipsihand Upper Extremity Rehabilitation SystemNeurolutions, IncQOL2022-09-12