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510(k) Data Aggregation
K Number
K230566Device Name
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Manufacturer
Joytech Healthcare Co.,Ltd
Date Cleared
2023-08-25
(177 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Joytech Healthcare Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 36cm or 22cm to 42cm or 32cm to 48cm.
The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 13.5cm to 21.5cm.
Device Description
The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement is compare 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 heartbeat when the difference of the time intervals is over 25%.
Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.
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K Number
K212115Device Name
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Manufacturer
JOYTECH HEALTHCARE CO.,LTD
Date Cleared
2022-01-05
(182 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
JOYTECH HEALTHCARE CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.
Device Description
The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.
The pulse rate measurement is compare 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 heartbeat when the difference of the time intervals is over 25%.
Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.
Unlimited readings can be stored in the app for archiving and review by the user.
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K Number
K183393Device Name
Digital Thermometer
Manufacturer
Joytech Healthcare Co.,Ltd
Date Cleared
2019-11-18
(346 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Joytech Healthcare Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Device Description
The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.
The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).
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K Number
K181239Device Name
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Manufacturer
Joytech Healthcare Co.,Ltd
Date Cleared
2018-10-29
(172 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Joytech Healthcare Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
Device Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead. The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead. The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode. In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.
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K Number
K173024Device Name
Non-invasive blood pressure measurement systems
Manufacturer
Joytech Healthcare Co.,Ltd
Date Cleared
2018-08-22
(328 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Joytech Healthcare Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.
Device Description
The arm-type series use an inflatable cuff which wraps around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.
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