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510(k) Data Aggregation
K Number
K242876Device Name
Pulse Oximeter ( PO2, PO2A, PO2B)
Manufacturer
Shenzhen Viatom Technology Co., Ltd.
Date Cleared
2025-02-28
(158 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
Device Description
The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.
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K Number
K203812Device Name
Oxyfit Pulse Oximeter
Manufacturer
Shenzhen Viatom Technology Co., Ltd.
Date Cleared
2022-11-08
(680 days)
Product Code
DQA, DOA, MWI
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.
Device Description
The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment. The Pulse Oximeter has two models, PO6 and PO6A, which are almost the same (include principle, structure, material, production process, performance) except appearance color. The device consists of main unit, SpO2 sensor and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by internal battery. The device is not for life supporting or life-sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
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K Number
K193348Device Name
Blood Pressure Monitor
Manufacturer
Shenzhen Viatom Technology Co., Ltd.
Date Cleared
2020-06-25
(205 days)
Product Code
DXN, DPS
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Pressure Monitor is indented to measure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.
Device Description
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure, pulse rate and ECG of an individual intended for home use. By using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm, the device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which deternines pulse rate, as well as systolic and diastolic blood pressure, which is a well-known technique in the market called the "oscillometric method". In addition to the BP measurement, the device also incorporates electrodes capable of gathering ECG data from the user. This can be done as a separate function. To initiate the ECG, the user places one or more fingers in contact with the electrodes on the right and left side of the device. The electrodes measure a single-lead ECG between left and right fingers. The single-lead ECG data is displayed on the LCD. The main components of the Blood Pressure Monitor are the main unit, cuff unit and ECG unit (only for BP2). The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Nylon and polyester 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 power on/off key, the pump, exhaust valve, bluetooth transmission, cuff and ECG circuit including the electrodes. The subiect devices are powered by Li-ion Polymer Battery. The device has Irreqular beat: If the change speed of heart rate exceeds a certain threshold during measurement, is judged as irreqular heartbeat. The subject device includes bluetooth transmission which can transfer data to other device through the bluetooth connection such as smart phone.
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K Number
K191088Device Name
Checkme O2 Pulse Oximeter
Manufacturer
Shenzhen Viatom Technology Co., Ltd.
Date Cleared
2019-12-02
(222 days)
Product Code
DQA, DOA, MWI
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
Device Description
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
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K Number
K190207Device Name
Blood Pressure Monitor
Manufacturer
Shenzhen Viatom Technology Co., Ltd.
Date Cleared
2019-08-19
(196 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.
Device Description
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive 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 Blood Pressure Monitor are the main unit and cuff unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Polyester 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 power on/off key, the rubber bulb, exhaust valve, bluetooth tranismision and cuff. The subject devices are powered by Li-ion Polymer Battery.
The device has irregulae heart beat (IHB) indicator which is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
The subject device includes bluetooth tranismision which can tranfer data to APP installed in smart phone. The APP can display, store and review the measurement data including the systolic and diastolic blood pressure and pulse rate.
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K Number
K150869Device Name
Checkme Pro Health Monitor
Manufacturer
Viatom Technology Co., Ltd.
Date Cleared
2015-12-10
(253 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Viatom Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
Device Description
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
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