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Taidoc Td-11 Series and Clever Td-1112 Ear Skin Surface Ir Thermometers Fora IR16 17 Ear Thermometer
Taidoc Technology
Summary: The Taidoc TD-11 Series and Clever TD-1112 are infrared thermometers used for measuring ear and skin surface temperatures. They are commonly used by healthcare professionals in clinical settings for quick and non-invasive temperature assessments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083299 ↗
Decision Date ?
December 10, 2008
Product Code ?
FLL
Device Class ?
Class 2
Evidence ?
0 studies
The Taidoc TD-11 Series and Clever TD-1112 thermometers were cleared through the FDA 510(k) pathway on December 10, 2008. Manufactured by Taidoc Technology, these devices are classified as Class 2 under product code FLL.
What It Is
The Taidoc TD-11 Series and Clever TD-1112 are infrared thermometers designed to measure temperature from the ear or skin surface. These devices use infrared technology to detect heat emitted by the body, providing a quick and accurate temperature reading. They are particularly useful in settings where rapid temperature assessment is critical, such as in emergency rooms or during routine clinical examinations.
FDA-Cleared Indications
- Measurement of body temperature from the ear.
- Measurement of skin-surface temperature.
- Use in patients across the labeled age range, as specified in the device instructions for use.
Clinical Applications
- Obtaining an ear temperature during a clinical examination.
- Obtaining a skin-surface temperature when noninvasive measurement is needed.
- Screening for elevated or reduced body temperature in healthcare settings.
- Temperature assessment in pediatric, adult, and older-adult patients when permitted by the device labeling.
Practical Considerations
- Use the correct measurement mode and technique for ear versus skin-surface readings.
- Follow the manufacturer’s instructions for probe positioning, distance, ambient conditions, calibration, and cleaning.
- Clean and disinfect the device as directed between patients; do not immerse the thermometer unless the labeling permits it.
- Readings may be affected by earwax, improper positioning, recent exposure to heat or cold, perspiration, or differences between measurement sites.
- These are electronic infrared devices and should not be assumed to be MRI safe; keep them outside the MRI environment unless the manufacturer has specifically documented MR safety or conditional use.
Frequently Asked Questions
What is Taidoc TD-11 Series and Clever TD-1112 used for?
These devices are used for measuring body temperature via the ear or skin surface using infrared technology.
What specialties typically use this device?
Pediatrics, general practice, and emergency medicine are common specialties that use these thermometers.
What are the FDA-cleared indications?
The thermometers are indicated for measuring body temperature from the ear or skin surface in patients of all ages.
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.