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510(k) Data Aggregation
K Number
K171668Device Name
Bluetooth blood pressure monitor
Manufacturer
Date Cleared
2018-02-26
(266 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Visiomed Group SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
Device Description
BW-BA1 Bluetooth Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method during inflating @ 3~8mmHg/second from about 30mmHg by inflating a cuff on the upper arm. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. An irregular heartbeat rhythm is defined as rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
BW-BA1 Bluetooth Blood Pressure Monitor without any display component achieves its function by integrating the device with a collateral device iPhone, iPad with a specific mobile app to constitute a complete blood pressure measurement system. And the new device connects the mobile platform with the mobile app through Bluetooth 4.0.
The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by WHO.
The BW-BA1 is powered by a rechargeable Lithium battery.
The device has an ON/START button for starting the measuring and stopping the measuring at any time when measuring.
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K Number
K112929Device Name
THERMOFLASH(TM) INFRARED THERMOMETER
Manufacturer
Date Cleared
2011-10-18
(15 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
VISIOMED GROUP SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ThermoFlash™ is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contacting to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Device Description
ThermoFlash™, including LX-26, LX-261, LX-260 and LX-260T, are handheld electronic thermometer that measures the body temperature based on the infrared sensor technology. All objects emit energy by radiation. The intensity of this energy depends on the temperature of the object. ThermoFlash™ is, therefore, able to measure the temperature of a person by the energy the person emits. Infrared sensor can sense the infrared emissions from the human body (forehead) and environment; then the electronic signal will be transferred by AD module to the digital signal and displayed on the LCD screen.
- A LX-26 is a thermometer with basic temperature measurement functions.
- A LX-260 is an advanced model to LX-26, which provides three additional keys which allow user to select the measurement directly;
- ア LX-261 is an advanced model to LX-260, which provides a rechargeable station base and inner Li rechargeable battery which can be recharged;
- LX-260T is an advanced model, which provides voice indicating of measured temperature.
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