đź“Š Evidence-Based Reference
computer interface - biofeedback
M.O.E Electronics Research & Prod.
Summary: The computer interface - biofeedback device by M.O.E Electronics is primarily used for neurofeedback and rehabilitation. Key evidence highlights its potential in post-stroke rehabilitation and improving motor control.
FDA Clearance Information
Pathway
510K
Number
K850759 ↗
Decision Date
May 23, 1985
Product Code
HCC
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510k pathway on May 23, 1985. It is manufactured by M.O.E Electronics Research & Prod. and classified as a Class 2 device under product code HCC.
What It Is
This device is a biofeedback computer interface designed to facilitate neurofeedback and rehabilitation. It interfaces with the brain to aid in motor control and rehabilitation, particularly in neurological conditions.
Clinical Applications
Commonly used in post-stroke rehabilitation to improve motor function and in conditions requiring neurofeedback. It is applied in scenarios where enhancing motor control and sensory feedback is critical.
Evidence Summary
The literature includes 15 studies ranging from 2014 to 2025, encompassing various study types such as RCTs and case series. These studies explore the device's efficacy in neurofeedback and rehabilitation.
Reported Outcomes
Published studies report improvements in motor control and rehabilitation outcomes, particularly in post-stroke patients. The device has shown potential in enhancing quality of life by aiding motor recovery.
Safety Profile
Reported complications include minimal adverse events, with most studies focusing on efficacy rather than safety. The device is generally well-tolerated in clinical settings.
Evidence Limitations
Evidence gaps include a lack of large-scale RCTs and long-term safety data. Further research is needed to establish comprehensive safety profiles and efficacy across diverse populations.
Frequently Asked Questions
What are the clinical indications for computer interface - biofeedback?
The device is indicated for neurofeedback and rehabilitation, particularly in post-stroke motor recovery.
What outcomes have been reported in clinical studies?
Studies report improvements in motor control and rehabilitation outcomes, especially in post-stroke patients.
What complications have been reported?
Safety data indicates minimal adverse events, with the device being generally well-tolerated.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.