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 ?
510(k)
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.
FDA-Cleared Indications
- Measurement of body temperature using infrared detection from the ear or skin surface.
- Noninvasive temperature assessment when an ear or skin-surface measurement is appropriate.
Clinical Applications
- Measuring temperature through the ear.
- Measuring temperature from the skin surface.
- Rapid temperature assessment in healthcare settings.
- Temperature monitoring when invasive or mucosal measurement is not preferred.
Practical Considerations
- Use the ear probe or skin-surface method according to the device instructions; positioning and technique can affect accuracy.
- Clean and handle the probe as directed by the manufacturer, particularly when used between patients.
- These are diagnostic thermometers, not implantable or therapeutic devices.
- They do not require MRI compatibility assessment as implanted devices, but should not be taken into the MRI scanner room unless facility safety procedures permit it.
- The FDA record identifies the devices as Class II products under product code FLL; battery life, calibration intervals, and replacement requirements depend on the manufacturer’s instructions.
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.