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510(k) Data Aggregation
K Number
K133588Device Name
FORA CARE BLOOD PRESSURE MONITORING SYSTEM
Manufacturer
FORA CARE INC.
Date Cleared
2014-04-25
(155 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FORA CARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fora Care Blood Pressure Monitoring System is a system designed 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. It is intended for individuals age 18 and above use at home and in clinical settings. The device is not to be used for the diagnosis of hypertension or for testing on newborns.
Device Description
Fora Care Blood Pressure Monitoring System (Model: P80) can be operated by the device itself or with the TDLink BP App. TDLink BP App is designed to assist in blood pressure testing, recording, tracking and monitoring in easy.
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K Number
K121706Device Name
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
FORA CARE INC.
Date Cleared
2013-01-14
(220 days)
Product Code
CGA, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
FORA CARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FORA V10 No Code Blood Glucose Monitoring System, model TD-4244, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but has not been validated for use by visually impaired users. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
This system is intended to be used by a single patient and should not be shared.
FORA V10 test strips are for use with FORA V10 No Code Blood Glucose meter model TD-4244 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm calf and thigh.
The FORA control solutions can only be used with FORA V10 No Code Blood Glucose meter, model TD-4244 and the FORA V10 test strips to check that meter and test strips are working together properly.
The alternative site testing in FORA V10 No Code Blood Glucose Monitoring systems model TD-4244 can be used only during steady-state blood glucose conditions.
Device Description
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA V10 test strips and FORA control solutions with the FORA V10 No Code Blood Glucose Monitoring System, model TD-4244.
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K Number
K121118Device Name
FORA COMFORTSCAN EAR THERMOMETER
Manufacturer
FORA CARE INC.
Date Cleared
2012-06-15
(64 days)
Product Code
FLL, CLI
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
FORA CARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
Device Description
FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.
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K Number
K110044Device Name
FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
Manufacturer
FORA CARE INC.
Date Cleared
2011-07-07
(182 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FORA CARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Device Description
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System.uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with a inflatable arm cuff on adults.
The device has single measurement mode, averaging mode and auscultatory mode of blood pressure measurements. The single measurement mode functions like a regular blood pressure monitor. The averaging mode is selected for performing three consecutive measurements with a fixed resting period between each measurement and displays the averaged result on LCD. The auscultatory mode is selected for trained persons to measure with a stethoscope.
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