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510(k) Data Aggregation
K Number
K220276Device Name
Infrared Thermometer TET-351
Manufacturer
Truly Instrument Limited
Date Cleared
2023-02-17
(382 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Truly Instrument Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.
Device Description
The TRULYL Infrared thermometer TET-351 is a hand-held, battery powered device designed to measure the body temperature through receiving infrared energy radiation via the ear canal or forehead. The thermometer has the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The results measured by TET-351 can also be transmitted to APP to record and display through Bluetooth.
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K Number
K192023Device Name
Arm Blood Pressure Monitor
Manufacturer
Truly Instrument Limited
Date Cleared
2019-12-23
(147 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Truly Instrument Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Device Description
Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
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K Number
K161846Device Name
Automatic Arm Bluetooth Blood Pressure Monitor
Manufacturer
TRULY INSTRUMENT LIMITED
Date Cleared
2016-10-24
(111 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
TRULY INSTRUMENT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Device Description
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AA alkaline batteries.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
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K Number
K090564Device Name
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
Manufacturer
TRULY INSTRUMENT LIMITED
Date Cleared
2009-06-24
(114 days)
Product Code
FLL, DEV
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
TRULY INSTRUMENT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Truly TET-350 TET-370 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 in the home setting.
Device Description
Truly Infrared Ear Thermometer TET-350 TET-360 TET-370
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K Number
K081852Device Name
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
Manufacturer
TRULY INSTRUMENT LIMITED
Date Cleared
2008-12-12
(165 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
TRULY INSTRUMENT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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