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This product is indicated for measuring blood pressure and pulse rate in patients older than 12 years. It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

YUWELL® Blood Pressure Monitor (Model: YE650AR) is a rechargeable lithium battery-powered, automatic, noninvasive, upper-arm blood pressure measurement system intended for use by adults. The YE650AR is designed for upper arm circumference ranging from 22 cm to 32cm (8.7 in to 12.5 in) or 22 cm to 45 cm (8.7 in to 17.7 in). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During deflation, the cuff pressure is monitored, and pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.

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The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Wrist Blood Pressure Monitor, model: BPM-W1VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

It measures blood pressure and pulse rate through inflating cuff which rounding the wrist of patients. The BPM-W1VL is small, portable and used at home or in medical facilities environment.

The Wrist Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-W1VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD.

Principle of operation: This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate. And Wrist circumference is 13.5-21.5 cm.

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Arm-type Fully Automatic Digital Blood Pressure Monitors(Model: DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L, DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L) 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 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L-P, DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)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 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L, DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L,) 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 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model:DBP-61D2L-P,DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)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 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

They are automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at 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 inflation measurements, an electric pump within the main unit slowly inflates the arm 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%.The devices are not intended to detect atrial fibrillation or any other arrhythmias. The Irregular heartbeat indicator is solely intended as a technical error/indicator. Irregular heartbeat rhythm is defined as rhythm that is either 25% slower or faster than the average rhythm detected while measuring systolic blood pressure and diastolic blood pressure.

DBP-62F4L, DBP-62F4B, DBP-62F4L-P, DBP-62F4B-P with bluetooth function can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD display of the device appears results. And the device will start to transmit data to the pair-up terminal automatically.

DBP-63D2L, BP-63D9L, DBP-63D2L-P, DBP-63D9L-P with additional WiFi function can also allow users better receive measurement result on mobile phone.

With the use of software (including APP) and wireless communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled 'Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices' (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.

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The Wearable Ambulatory Blood Pressure Monitor, model WBP-02A is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to measure systolic and diastolic pressure in individuals aged 12 years and older. The collected data can be transmitted to a PC via USB for healthcare professionals to review and analyze. This device is not intended for diabetic patients, pregnant women, or patients with arrhythmia. It is intended for prescription use only.

The WBP-02A Ambulatory Blood Pressure Monitor from Hingmed Medical comprises a main unit, a cuff, a USB data cable, and PC analysis software. This compact and portable device is worn comfortably on the patient's upper arm. The cuff inflates to occlude the brachial artery and then gradually deflates. The device employs the oscillometric method to measure blood pressure and pulse parameters during the deflation phase, capturing the transition from blood flow occlusion to restoration. The main unit's internal memory can store up to 300 measurement records. Upon completion of the monitoring period, the data is transferred via the USB cable to a computer for comprehensive statistical analysis using the dedicated software.

The ambulatory blood pressure monitor software has two components: embedded software and PC software.

The embedded software runs on the main control unit, directing the monitor to take measurements and collect blood pressure data, which it sends to the PC software via USB. The PC software analyzes the data, generates charts for medical review, and can also configure the device—such as setting measurement intervals—and initiate readings.

The PC software operates offline and does not replace any tasks performed by healthcare professionals.

The device firmware does not include the calculation function for Mean Arterial Pressure (MAP), and the OLED screen on the host device does not display MAP values. The accompanying PC software can display the hourly average MAP value and its trend graph. MAP is calculated using the standard equivalent formula, as follows:

Calculation Formula: MAP = (SBP + 2 x DBP) / 3
Alternative expression: MAP = DBP + (1/3) x PP

Where:

• SBP = Systolic Blood Pressure
• DBP = Diastolic Blood Pressure
• PP = Pulse Pressure (SBP – DBP)

Note on the Formula:
The expression "MAP = (SBP + 2 x DBP) / 3" is mathematically equivalent to the standard MAP formula "DBP + 1/3 x (SBP – DBP)".

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This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose.

Environments of use: Hospital and other medical establishment(contraindicate the home as an environment of use).

Patient population: Adult (exclude pregnant women ).

Clinical Automatic blood pressure monitor have two type that is DBP-20 and DBP-20i,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body、power adapter.The device can show the time and measure result .There is a difference DBP-20 and DBP -20i. The difference is the function with voice broadcast . DBP-20i have the function which broadcast the measure result.and DBP-20 have not the broadcasting function.

Clinical Automatic Blood Pressure Monitor is intended to be used for arms range from 17 to 42cm in circumference. The cuff cover can be replace easily. The device intended use at medical center .

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The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate.

This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

No operation for 1 minute the device will shut down automatically.

The subject device includes model MJ1DS/MJ1D/MJ3D/MJ5D/MJ6D/MJ8D/RN3D/MJ4D/RN1D/RN2D. These models are identical in terms of software design, cuff type, measurement range and function, principle, the core algorithm of the software, the key components. The schematic circuit diagrams are identical in all models. The PCB layout are identical in all models because of different appearance such as structure, buttons layout.

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The Arm Blood Pressure Monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.

The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x60 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

No operation for 1 minute the device will shut down automatically.

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The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.

The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.

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The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).

The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the 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 sensor to determine systolic pressure and diastolic pressure.

The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.

This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.

This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).

The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.

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