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palmo thermoregulation interface accessory
Avacore Technologies
Summary: The palmo thermoregulation interface by Avacore Technologies is a Class 2 medical device used to manage body temperature during medical procedures. It is typically used by clinicians in surgical and oncological settings.
FDA Clearance Information
Pathway
510K
Number
K014210 ↗
Decision Date
August 16, 2002
Product Code
DWJ
Device Class
Class 2
Evidence
0 studies
The palmo thermoregulation interface was cleared via the FDA 510k pathway on August 16, 2002. Manufactured by Avacore Technologies, it is classified as a Class 2 device.
What It Is
The palmo thermoregulation interface is a device designed to regulate body temperature through controlled thermal exchange. It works by applying a temperature-controlled medium to the palm, which is a highly vascular area, facilitating efficient heat transfer. This device is particularly useful in maintaining normothermia during surgical procedures, thereby reducing the risk of complications associated with hypothermia.
Clinical Applications
This device is commonly used in surgical settings, particularly during lengthy procedures where maintaining patient body temperature is critical. It is also utilized in oncology for patients undergoing tumor ablation, where precise temperature control can aid in the effectiveness of the treatment. The device is suitable for use in both adult and pediatric populations, making it versatile across various clinical scenarios.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring precise thermoregulation, such as surgeries and tumor ablations. It is intended for patients who need controlled body temperature management to prevent complications like hypothermia.
Practical Considerations
The device typically comes in various sizes to accommodate different patient needs and is compatible with standard surgical equipment. Clinicians should ensure proper placement and secure attachment to maximize thermal exchange efficiency. Regular calibration and maintenance are recommended to ensure optimal performance.
Frequently Asked Questions
What is the palmo thermoregulation interface used for?
It is used to manage and regulate body temperature during medical procedures, such as surgeries and tumor ablations.
What specialties typically use this device?
The device is commonly used by surgeons, anesthesiologists, and oncologists in hospital and surgical center settings.
What are the FDA-cleared indications?
The device is indicated for use in maintaining body temperature during medical procedures, particularly in surgeries and tumor ablation treatments.
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.