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510(k) Data Aggregation
K Number
K100226Device Name
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
Manufacturer
RIO FLEXON TECHNOLOGY CO., LTD.
Date Cleared
2010-03-18
(52 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RIO FLEXON TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wireless Body Temperature Monitor, model BTM-D1X series (model BTM-D1C, D, E, F, G and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two years old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, G and H, have only the function of ampit temperature monitoring.
Device Description
The Wireless Body Temperature Monitor BTM-D1X series includes models BTM-DIC, D, E, F, G and H. This device is a battery-operated electronic device that is intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has the additional function of an ear thermometer.
The device is composed of two operational parts, the receiver and armband. An optional accessory may be included to assist in affixing the sensor of the armband more tightly. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit, and the main operation keys are included. The armband was designed and constructed with a thermo sensor and signal communication unit. For the monitoring operation, both the receiver and armband must be switched on. Soon after these two parts are switched on, the wireless signal communication will set up between the receiver and the armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of the receiver and will update every 12 seconds.
The device also has a high/low audible alarm, which will sound if the body temperature goes above the high alarm temperature or below the low alarm temperature set by the user.
In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on the receiver to take an ear temperature measurement at any time if needed. The reading on the LCD screen will return to the armpit temperature after 30 seconds.
This system uses a 3.0V DC battery for operation of the complete system. Whenever the battery is low, the MCU circuit will detect the low battery condition automatically, and will display "Low battery" on the LCD display. The BTM-D1X series was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.
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K Number
K081256Device Name
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
Manufacturer
RIO FLEXON TECHNOLOGY CO., LTD.
Date Cleared
2008-05-27
(25 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RIO FLEXON TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wireless Body temperature monitor, model BTM-D1x series (model BTM-D1C, D, E, F, G and H) is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitors armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years old. In which, model BTM-D1C is with two functions of ear temperature measurement and armpit temperature monitor; the rest of models, BTM-D1D, E, F, G and H are only with the function of armpit temperature monitor.
Device Description
The Wireless body temperature monitor, BTM-D1X series include the BTM-D1C, D, E, F, G and H, which are the battery-operated electronic devices with intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has additional function of ear thermometer.
The device is composed of two operational parts, the receiver and armband. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit and the main operation keys are included. And the armband was designed and constructed with the thermo sensor and the signal communication unit. For the monitoring operation, both receiver and armband shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 12 sec.
In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on receiver to take temperature measurement on ear any time if needed. The LCD will be returned to armpit temperature monitor after 30 sec.
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K Number
K062445Device Name
MONITORING EAR THERMOMETER, MODEL BTM-D1A
Manufacturer
RIO FLEXON TECHNOLOGY CO., LTD.
Date Cleared
2007-02-16
(178 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RIO FLEXON TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitor armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years olds.
Device Description
The Monitoring Ear Thermometer/model BTM-D1A is the combination device of ear thermometer and wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. BTM-D1A is composed of two operational parts, the receiver and armband. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit and the main operation keys are included. And the armband was designed and constructed with the thermo sensor and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and armband shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 12 sec. In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on receiver to take temperature measurement on ear any time he needs. The LCD will be returned to armpit temperature monitor as soon as the ear temperature measurement operation is completed. This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BTM-D1A, it was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.
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