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The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories. The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip. The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The system is not intended for use on patients receiving intensive medical intervention/therapy. The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.

The FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips. The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use). Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions). The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (k161738).

The Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241) is an infrared thermometer intended for the non-contact measurement of human body temperature in people of all ages and may be used by medical professionals or by consumers in a home environment.

The Clever Forehead Thermometer/Clever Medical Forehead Thermometer (TD-1241) is a handheld, battery powered, infrared forehead thermometer with a non-contact body temperature measuring function. It detects infrared energy emitted from forehead within 1.2 - 5 cm and converts to a body temperature. This device can be used on people of all ages by medical professionals and consumers in a home environment. The final measured temperature will be displayed on the LCD screen of the device. The users can transmit temperature results from the Clever Forehead Thermometer/Clever Medical Forehead Thermometer to Healthy Check on their mobile devices and Health care management system on pc via Bluetooth. The Healthy check and Health care management system provide an overview of users record with historical data and trend graph.

The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips. The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The TD-4183 system kit includes the TD-4183 Blood Glucose meter with blood glucose measuring function and the TD-4183 Blood Glucose test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control.

The FORA P100 Blood Pressure Monitoring System is intended to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. Do not use this system on babies, young children or persons who cannot express their consent.

FORA P100 Blood Pressure Monitoring System (Model: P100) can be operated by the device itself to assist in blood pressure testing, recording, tracking and monitoring in easy. The TD-3130 in report is an internal model and FORA P100 is the marketing name for this system.

The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

Prescription home use: The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions. The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional. Point-of-care use: The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only. This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout

FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.

The POPS!® one Blood Glucose Monitoring System is comprised of the POPS!® one blood glucose meter, the POPS!® one blood glucose sensor modules, and the POPS!® mobile application as the display component. The POPS!® one Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The POPS!® one Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

The POPS!® one Blood Glucose Monitoring System is designed to make blood glucose testing and diabetes management easier and more convenient. The traditional test kit is replaced by a low-profile meter that contains everything needed for testing and requires no assembly. The meter pairs with a mobile app installed on the user's phone via Bluetooth, allowing the meter to perform glucose testing and send the results to the app where they are communicated to the user and automatically stored. The POPS!® one Blood Glucose Monitoring System contains the following: - . POPS!® one blood glucose meter works directly with the POPS!® app installed on the user's mobile phone. The meter performs a blood glucose test and sends the result to the POPS!" app. - . POPS!® one blood glucose sensor module is individually packed and sterile. It contains 3 test sites with separate foil covers; each containing a lancet and test strip. The user inserts the sensor module in the meter and replaces a used sensor module with a new once all 3 test sites have been used. The sensor module not only provides all components for performing a glucose test to the user in a convenient, self-contained format but it also provides a new lancet for each test; preventing lancet re-use. - . POPS!® mobile application acts as the primary interface with users; enabling them to test, communicating blood glucose results and messages, and allowing them to monitor trends on their phone.

TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.

TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.

The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.