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surface electromyograph biofeedback muscle activity device
J-Tech
Summary: The surface electromyograph biofeedback muscle activity device by J-Tech is used for assessing and training muscle activity patterns. Key evidence supports its use in swallowing management and pelvic floor muscle training.
FDA Clearance Information
Pathway
510K
Number
K954737 ↗
Decision Date
July 3, 1996
Product Code
HCC
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on July 3, 1996. It is manufactured by J-Tech and classified as a Class 2 device under product code HCC.
What It Is
This device measures muscle activity through surface electromyography (sEMG) and provides biofeedback to aid in clinical applications such as motor learning and rehabilitation. It is intended for use in assessing muscle activity patterns and training strategies.
Clinical Applications
Commonly used in swallowing management, pelvic floor muscle training, and monitoring masticatory muscle activity. It provides real-time feedback to patients and clinicians to enhance rehabilitation outcomes.
Evidence Summary
The literature includes 12 studies, comprising randomized controlled trials and systematic reviews, published between 2020 and 2024. These studies explore the device's efficacy in various clinical scenarios.
Reported Outcomes
Published studies report that the device is effective in enhancing muscle activity during exercises such as the effortful swallow and pelvic floor muscle training. It has been shown to improve muscle contraction and retention performance in these contexts.
Safety Profile
Reported complications include minimal adverse events, with no significant safety concerns identified in the reviewed studies. The device is generally well-tolerated by patients.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the device's efficacy across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for the surface electromyograph biofeedback muscle activity device?
The device is indicated for use in swallowing management, pelvic floor muscle training, and monitoring masticatory muscle activity.
What outcomes have been reported in clinical studies?
Studies have reported improved muscle activity and retention performance during exercises such as the effortful swallow and pelvic floor muscle training.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with no significant safety concerns identified.
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.