Neurolutions Ipsihand Upper Extremity Rehabilitation System
Basic Information
- Brand Name
- Neurolutions Ipsihand Upper Extremity Rehabilitation System
- Primary DI
- 00850005539018
- Version / Model
- FGS-1000-01
- Company Name
- Neurolutions, Inc
- Labeler DUNS
- 067760283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-12
- Public Version
- 1
- Public Version Date
- 2022-09-20
- Public Version Status
- New
- Public Device Record Key
- 088a7ee7-4ef1-48ed-9094-9d771a3fce9d
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QOL | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | Neurology | 890.5420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005539018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200046 | 000 |