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Clever Forehead Thermometer (Model TD-1241)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200946

by Taidoc Technology Corporation

Identifiers

510(k) Number
K200946 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Clever Forehead Thermometer (Model TD-1241) is an infrared, non-contact forehead thermometer designed for measuring human body temperature in individuals of all ages. It operates as a clinical-grade device, providing rapid and accurate readings without physical contact, making it suitable for both home and healthcare environments. The device leverages infrared technology to detect temperature via the forehead, ensuring minimal user interaction and hygiene compliance. Its classification aligns with non-invasive temperature monitoring devices, adhering to standards for precision and reliability in medical and consumer settings.

This thermometer is supplied as a single-use or reusable device (as per user discretion) and is intended for use in general hospital settings, as indicated by its FDA 510(k) clearance under the Traditional pathway. The Model TD-1241 is manufactured by Taidoc Technology Corporation and is assigned the product code FLL under the FDA’s nomenclature. No specific sterility or MRI safety information is provided in the available data. Storage conditions are not detailed, but typical infrared thermometers require protection from extreme temperatures and moisture. The device holds FDA 510(k) clearance (K200946) for substantial equivalence to a predicate device.

Frequently asked questions

What is the Clever TD-1241 infrared thermometer used for?

The Clever TD-1241 is designed for measuring human body temperature via infrared technology on the forehead. It is suitable for clinical-grade use in both healthcare and home environments, ensuring rapid, non-contact readings to minimize user interaction and maintain hygiene standards.

Is the Clever TD-1241 thermometer single-use or reusable?

The device can be used either as a single-use or reusable option, depending on user preference. However, no specific sterility information is provided, so proper cleaning and maintenance are recommended if reused to ensure accuracy and hygiene.

What regulatory clearance does the Clever TD-1241 hold?

The Clever TD-1241 holds FDA 510(k) clearance under the Traditional pathway, with a clearance number of K200946. It is classified under product code FLL and is intended for general hospital use, demonstrating substantial equivalence to a predicate device.

How should the Clever TD-1241 be stored?

While storage conditions are not explicitly detailed, typical infrared thermometers require protection from extreme temperatures and moisture. Store the device in a dry, stable environment away from direct sunlight or humidity to maintain its performance and longevity.

Does the Clever TD-1241 have any special safety considerations?

The device is designed as a non-invasive, non-contact thermometer, so no specific MRI safety information is provided. Users should follow standard hygiene practices if reusing the device, and ensure it is not exposed to conditions that could compromise its accuracy or integrity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Non Contact Forehead Thermometer | Bluetooth | TaiDoc TD-1241, Non Contact Forehead Thermometer | Bluetooth | TaiDoc TD-1241, Clever Forehead Thermometer / Clever Medical Forehead Thermometer ..., Taidoc TD-1241 Non-contact Forehead Thermometer

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K200946 24 fields · synced Oct 1, 2026