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The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.

The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.

The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.

The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in software.

The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.

The proposed device of Fingertip Pulse Oximeter MD300C318T2 is a battery powered fingertip device, with the Durable and Deluxe design. The new kind of fingertip pulse oximeter integrated with Bluetooth wireless technology is designed to monitor SpO2 and pulse rate and connect with telemedicine. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, user interface. The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed device are 2 AAA alkaline batteries. The proposed device has low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in Section of Software.

The external pulse oximeter (MD50i and MD50p) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult at hospital. This medical device can be reused. Not for continuous monitoring.

The MD50I includes three main parts as SpO2 probe, SpO2 module and 30 pin port. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the 30 pin port is used to connect with iPhone device for digital signal transmission. The MD50I includes two parts of software, Upper Computer software (Mobile App) and Low Computer Software. The Upper Computer software is installed in the iPhone device, which is used to receive the measured data (SpO2 and PR) from the MD50I, which has the following functions: - Measured data (SpO2 and PR) receiving; - Display the measured data (SpO2 and PR) in real time; - Graph of the measured data (SpO2 and PR) based on the day/week/month or all of observed data trend. - Measured data (SpO2 and PR) reviewed, the day/week/month history data could be reviewed; - Note function, the user can make comments after specified history record; - History data delete, the user can delete the history records; - Personal information edit, the user can input their own information and save it; - Share function, the user can select the specified history record to share with others by email; The Low computer software is embedded in the MD501, which includes the SpO2 sensor and has the following functions: - Collect the SpO2 and PR data from patient; - Transform the electrical signal to digit signal; - Send the digit signal to the Upper Computer software for display and following process. The MD50P includes three main parts as SpO2 probe, SpO2 module and USB plug. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the USB is used to connect with PC device for digital signal transmission. The MD50P includes two parts of software. Upper Computer software (PC App) and Low Computer Software. The Upper Computer software is install in the PC device, which is used to receive the measured data (SpO2 and PR) from the MD50P, which has the following functions: - Insert device identified automatically; - Measured data (SpO2 and PR) receiving; - Display the measured data (SpO2 and PR) in real time; - Oxygen saturation, Pulse rate, Pulse bar and waveform are clearly displayed on PC when doing real-time measuring; - Save the current data into your PC with the format of "txt", "pdf", "xls"; - Data print; - Personal information edit, the user can input their own information and save it, such as title, patient ID, name, gender, age, height, weight, physician comments; - Alarm set, set the high/low SpO2 limit and high/low PR limit; - Saved data reviewed. - Login interface, the user needs input password and user name to access the account. The Low computer software is embedded in the MD50P, which includes the SpO2 sensor and has the following functions: - Collect the SpO2 and PR data from patient; - Transform the electrical signal to digit signal; - Send the digit signal to the Upper Computer software for display and following process.

The Fingertip Pulse Oximeter MD300CL37 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities, and home environments.

The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface. The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically. The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in Section of Software.

The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.

The proposed device Fingertip Pulse Oximeter MD300C29-H is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, child and adolescent patient in the hospital. The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software -driven and the software validation is provided in Software

The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient in hospital.

The applicant device of Fingertip Pulse Oximeter MD300CB3 is a battery powered fingertip device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, adolescent, child and infant patient in hospital. The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The devices are software -driven and the software validation is provided in Software.

The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).

The proposed devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display SpO2 and pulse rate value. The proposed devices consist of detector and emitter LED, signal amplify unit, CPU, display unit and power unit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 940 nm, which is infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds. The proposed devices of MD300CF3 and MD300CF61 have pulse rate tone modulation function. The function of pulse rate tone modulation is that the device can make a sound of Di-Di-Di to reflect pulse rate in real time. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Fingertip Pulse Oximeters MD300C series share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Fingertip Pulse Oximeters MD300C series are the same. The devices are software-driven and the software validation is provided in Section of Software

The Fingertip Pulse Oximeter MD300CF315 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is not for continuous monitoring.

The applicant device of Fingertip Pulse Oximeter MD300CF315 is a battery powered fingertip device, which can detect, display and speak out the measured %SpO2 and pulse rate value. The device is normally applied to adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The devices are software -driven and the software validation is provided in Section 11 Software.

The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc).

The proposed device MD300W4 consists of MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit. It can measure, store, review and display the SpO2% and pulse rate value, time, ID number, pulse bar and battery power status, the connection of probe, and transmit data by GPRS or USB cable. The power supply is 4.2V Li-battery with capacity 1250mAh. The device can not be used to measure when it charges for the Li- battery. The Pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in probe collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device has one model detachable sensor as the accessory of which the skin-contacting material is silicon. It is listed below: M-50G (510(k) number: K082487) The proposed device is not for life-supporting or life-sustaining, not for implant. The device or probe is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in Section 14 Software on page 14-1.