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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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K Number
K130361Device Name
THERMOFINDER; THERMOCARE
Manufacturer
HUBDIC CO., LTD
Date Cleared
2013-04-02
(48 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 Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.
Device Description
The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.
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K Number
K101912Device Name
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
Manufacturer
HUBDIC CO., LTD
Date Cleared
2010-11-10
(124 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 Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.
Device Description
The Infrared Forehead Thermometer, Modelfype FS-300&301 is an electronic thermometer using an infrared i sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. This product is an Infrared Forehead Thermometer with measuring room temperature and relative humidity.
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K Number
K080636Device Name
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
Manufacturer
HUBDIC CO., LTD
Date Cleared
2009-02-13
(344 days)
Product Code
CGA, DXN, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HUBDIC CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Duo-Max Blood pressure and Glucose Monitor, Model HMF-100 consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric metric method of measurement.
The Blood pressure and glucose monitor. Duo-Max™ consists of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whole blood taken from the fingertip, dorsal hand, ventral palm, upper arm, forearm, calf and thigh. Glucose testing is done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillomentric metric method of measurement.
Device Description
HuBDIC's Duo- Max Blood Pressure and Glucose Monitor System, Model HMF-100 combines the function of a blood pressure meter and a blood glucose monitoring system in one unit. Supplies with the meter are test strips, lancets, Lancing device, storage case, batteries and log book.
HMF-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface pane has power switch, timer switch, memory switch for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 180 most recent measurement results.
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K Number
K043331Device Name
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
Manufacturer
HUBDIC CO., LTD
Date Cleared
2005-03-04
(92 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
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature over the temporal artery on the forehead. It is intended for people of all ages.
Device Description
hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery.
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K Number
K023412Device Name
THERMO BUDDY, MODELS TB-100, TB-110, TB-120
Manufacturer
HUBDIC CO., LTD
Date Cleared
2003-04-09
(180 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
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used at home.
Device Description
The Thermo Buddy Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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