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510(k) Data Aggregation
K Number
K191978Device Name
Fever Garde
Manufacturer
HuBDIC Co., Ltd.
Date Cleared
2020-12-18
(513 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HuBDIC Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
Device Description
The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heat and measures the temperature using a resistance that changes with heat. Displays the highest temperature among consecutive temperature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. This product is in conjunction with the App, and information can be checked through a mobile device. Application Name: H-Health. The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.
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