Device Information

Indications

The Digital Thermometer Model T28 T28L measures and monitors human body temperature through oral or axillary sites. It is suitable for people of all ages and can be used by doctors or users in hospitals or at home.

• MedDRA Code: 10003401 (Indication for measuring body temperature)

Intended Use

It is intended for use in both hospital and home settings. The thermometer can be used on individuals of all ages and is designed to measure temperature through oral or axillary (underarm) sites. The device is suitable for healthcare professionals (doctors and nurses) or individuals at home for personal health monitoring. 

Availability 

• Over the counter 

Limitations

The device is for use in oral and axillary measurements only. Its accuracy and safety in other body sites or under different conditions have not been validated.

Regulatory Information

The device complies with 21 CFR 880.2910 for Clinical Electronic Thermometers. This device has been determined substantially equivalent to legally marketed predicate devices, allowing it to be sold under the general controls of the Federal Food, Drug, and Cosmetic Act.

Manufacturer Information

Guangdong Genial Technology Co., Ltd., is located in Shenzhen, Guangdong, China.

Predicate Device Information

The device has been found substantially equivalent to legally marketed predicate devices that were available before May 28, 1976, or devices that have been reclassified.

Implications

This device’s clearance under 510(k) allows for its use in clinical and home settings for temperature measurement, providing an accessible and reliable option for monitoring human body temperature.

References

• Device Name: Digital Thermometer Model T28 T28L. 510(k) Number: K232678. FDA Summary Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232678