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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 42cm and 40cm-56cm.

The Arm-type Blood Pressure Monitor (BPM) series is an 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 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 per minute. The DBP-6286B embed bluetooth module to transfer data to APP. With the use of software (including APP) and Bluetooth 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.

The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood Pressure (systolic and diastolic) of adults and adolescents over 12 years of age with circumference ranging from 22cm to 24cm.

The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is 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 systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg. Meanwhile, some models whith 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 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 measurement results from the blood pressure monitor device, 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. There are total 7 arm-type blood pressure monitor models we submitted: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6193 and they are both bodyworn medical devices.

The Electric Breast Pump (Model LD-208L, LD-3010L, LD-3010, LD-2010) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump (LD-208L, LD-3010L, LD-3010, LD-3010, LD-2010) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The subject devices are capable of expression, stimulation, and the hybrid 'bionio' and 'variable frequency' modes. Stimulation mode is associated with six suction levels, and expression, bionic, and variable frequency modes are associated with nine suction levels. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator display, and mode displays. The LD-208L, LD-3010L, and LD-2010L pumps are powered by internal, nonreplaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The LD-2010 and LD-3010 are powered by alkaline batteries or AC power. The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is pre-programmed in the devices. The devices are capable of producing peak suction levels between -40 and -290 mmHg at speeds between 20 and 120 cycles per minute. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device 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 Infrared Ear/Forehead Thermometer 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 results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone. The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system. The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information. The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions: l. data recording; II. curve display; III. alarm functions. The light bar of DET-218 turns on green light when the measurement is < 38.0 ℃ (100.4 °F ). The alarm function refers to the light bar of the device DET-218 turns on red light when the measurement is ≥38.0 ℃ (100.4 下 ), the APP will give an alarm when the measurement received simultaneously from DET-218 displays≥38.0℃.

The Digital Thermometer is 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.

The digital thermometer DMT-4735b is hand held instruments which can measure human body's temperature orally, axillary (under the arm), and rectally The results can be displayed on LCD. And, the results measured by DMT-4735b can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for clinical or home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane.DET-103 and DET-105 include probe cover that is optional. The Infrared Ear Thermometers include probe which used to measure ear canal temperature,plastic enclosed the display window,buttons and the battery cover.

The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile. The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle). The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release). The device has two modes of operation: - Stimulation mode: Suction patterns with fast cycles and low vacuum to start milk flowing - Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.

The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.

The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. 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 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.