đź“‹ FDA Reference
clever td-1107 ear skin surface ir thermometer clever td-1110 ear skin surface ir thermometer
Taidoc Technology
Summary: The Clever TD-1107 and TD-1110 are infrared thermometers designed for measuring ear and skin surface temperatures. They are used by healthcare professionals for quick and non-invasive temperature assessments.
FDA Clearance Information
Pathway
510K
Number
K050463 ↗
Decision Date
July 27, 2005
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The Clever TD-1107 and TD-1110 were cleared through the FDA 510(k) pathway on July 27, 2005. Manufactured by Taidoc Technology, these devices are classified as Class II under product code FLL.
What It Is
The Clever TD-1107 and TD-1110 are infrared thermometers used to measure temperature via the ear or skin surface. They operate by detecting infrared radiation emitted from the body and converting it into a temperature reading. These devices provide a quick, non-invasive method for temperature assessment, which is crucial in both clinical and home settings.
Clinical Applications
These thermometers are commonly used in pediatrics, general practice, and emergency medicine to quickly assess body temperature. They are particularly useful in settings where rapid temperature measurement is necessary, such as during triage in emergency departments or in pediatric clinics where patient compliance can be challenging. They are also suitable for use in outpatient settings and for home monitoring.
Indications for Use
The FDA indications suggest these devices are intended for measuring body temperature in patients where a non-invasive method is preferred. This includes patients of all ages, particularly those who may not tolerate oral or rectal thermometry.
Practical Considerations
The Clever TD-1107 and TD-1110 are designed to be user-friendly and require minimal training. They are typically compact and portable, making them easy to use in various clinical settings. It's important to ensure proper technique, such as correct positioning in the ear canal, to obtain accurate readings.
Frequently Asked Questions
What is Clever TD-1107/TD-1110 used for?
These devices are used for measuring body temperature via the ear or skin surface in a non-invasive manner.
What specialties typically use this device?
Pediatrics, general practice, and emergency medicine commonly use these thermometers for quick temperature assessments.
What are the FDA-cleared indications?
These devices are indicated for measuring body temperature in patients where non-invasive methods are preferred.
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.