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texas interface pressure evaluator-tipe
Tee-Kay Applied Technology
Summary: The Texas Interface Pressure Evaluator-TIPE is a device used for assessing pressure distribution, primarily in tumor ablation procedures. Key evidence highlights its role in optimizing pressure application for therapeutic outcomes.
FDA Clearance Information
Pathway
510K
Number
K831800 ↗
Decision Date
August 16, 1983
Product Code
JFC
Device Class
Class 1
Evidence
0 studies
The Texas Interface Pressure Evaluator-TIPE was cleared by the FDA via the 510(k) pathway on August 16, 1983. Manufactured by Tee-Kay Applied Technology, it is classified as a Class 1 device under product code JFC.
What It Is
The Texas Interface Pressure Evaluator-TIPE is a medical device designed to measure and evaluate pressure distribution across surfaces, particularly in the context of tumor ablation. It aids clinicians in ensuring optimal pressure application during procedures.
Clinical Applications
Commonly used in tumor ablation procedures, the device helps clinicians monitor and adjust pressure to improve therapeutic outcomes. It is also applicable in scenarios requiring precise pressure management, such as diabetic foot ulcer prevention.
Evidence Summary
The literature includes 10 studies, with a mix of study types such as RCTs and prospective studies, published between 2023 and 2024. These studies explore various applications of pressure management in clinical settings.
Reported Outcomes
Published studies report that the Texas Interface Pressure Evaluator-TIPE effectively aids in pressure management, contributing to improved outcomes in diabetic foot ulcer prevention and compression therapy. The device's role in optimizing pressure application is highlighted across multiple studies.
Safety Profile
Reported complications include the need for frequent adjustments due to changes in tissue properties and fabric characteristics. No significant adverse events were noted in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device's efficacy. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Texas Interface Pressure Evaluator-TIPE?
The device is indicated for use in pressure management during tumor ablation and in scenarios like diabetic foot ulcer prevention.
What outcomes have been reported in clinical studies?
Studies have reported effective pressure management, contributing to improved outcomes in diabetic foot ulcer prevention and compression therapy.
What complications have been reported?
Reported complications include the need for frequent adjustments due to changes in tissue properties and fabric characteristics.
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.