Thermo Buddy, Models TB-100, TB-110, TB-120

FDA 510(k)

Class II (US FDA 510(k))

510(k) K023412

Identifiers

510(k) Number: K023412 FDA 510(k)
FDA Product Code: FLL FDA 510(k)
Models / Variants: Tb-100 FDA 510(k)
Tb-110 FDA 510(k)
Tb-120 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 Thermo Buddy is a hand-held electronic clinical thermometer that measures natural thermal radiation from the tympanic membrane and adjacent auditory canal surfaces via an infrared sensor. It provides body temperature measurement to assist in health monitoring. The device is designed for use in a home setting by patients of all ages or caregivers.

The Thermo Buddy is supplied in models Tb-100, Tb-110, and Tb-120. It is used for measuring body temperature and is designed with infrared technology. The device has a diameter of 29 (W) mm / 45 (D) mm / 160 mm. It is intended for single-use with a disposable probe.

Frequently asked questions

What is the Thermo Buddy used for?

The Thermo Buddy is used for measuring body temperature to assist in health monitoring, designed for use in a home setting by patients of all ages or caregivers.

Is the Thermo Buddy supplied with a disposable probe?

Yes, the Thermo Buddy is intended for single-use with a disposable probe, which is supplied with the device.

What are the different models of the Thermo Buddy?

The Thermo Buddy is supplied in models TB-100, TB-110, and TB-120, all of which are hand-held electronic clinical thermometers using infrared technology.

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: THERMO BUDDY, MODELS TB-100, TB-110, TB-120 (K023412) — FDA 510 (k ..., Fever thermometer - TB-100 - HuBDIC - infrared / multifunction, HuBDIC Thermo Buddy Infrared Ear Thermometer - cakd.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K023412	Class II	Active

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Manufacturer

Manufacturer: HuBDIC Co., Ltd.

Sources (1)

FDA 510(k) K023412 24 fields · synced Sep 22, 2026