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510(k) Data Aggregation

    K Number
    K250470
    Device Name
    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2025-06-23

    (125 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.
    Device Description
    The ear thermometer is a handheld device that displays the temperature of the measured patient by measuring the thermal radiation of the eardrum. Measurement unit: °C or °F. The results can be displayed on LCD. The thermometers are powered by 1.5V×2 (AAA or AA) alkaline batteries, which can be used for people over three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum, which is converted into temperature measurement with the unit of °C or °F. All the models share the same critical components, intended use, working principle and similar product design, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, unit switch, low battery detection and high temperature indicator.
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    K Number
    K250161
    Device Name
    Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2025-05-02

    (101 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
    Device Description
    The Wrist Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. All the models included in this submission follow the the same intended use, same measurement principle, same blood pressure core algorithm and similar product design. All the models can be used with one cuff size 13.5~19.5 cm (5.3-7.7inches). The main differences are appearance, Dimensions and some specifications which will not affect the safety and effectiveness of the device.
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    K Number
    K232128
    Device Name
    Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2023-10-14

    (89 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
    Device Description
    The Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD and can also be transmitted to a non-device APP to record and display through Bluetooth. There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.
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    K Number
    K222994
    Device Name
    Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2023-07-26

    (301 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
    Device Description
    AOJ-33series arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device. AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.
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    K Number
    K221039
    Device Name
    Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2022-12-20

    (257 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
    Device Description
    The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E.
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    K Number
    K222125
    Device Name
    Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2022-12-01

    (136 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
    Device Description
    AOJ-30 series Arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the similar software, same measurement principle and same specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device. AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models.
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    K Number
    K221170
    Device Name
    Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2022-10-07

    (168 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healtheare environments.
    Device Description
    The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator.
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    K Number
    K213485
    Device Name
    Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2022-05-25

    (208 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home. The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.
    Device Description
    The digital thermometer is designed as hand-held device which can measure human body's temperature orally, axillary (under the arm), or rectally. The results can be displayed on LCD. The digital thermometers have several functions, such as beep indication, °C and °F unit switchable, low battery detection, memories, three-color backlight, auto automatic power off functions. The device is a predictive digital thermometer. Users only need 10 seconds for quick reading, and will display the temperature value on the screen.
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    K Number
    K213503
    Device Name
    Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2022-02-18

    (109 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
    Device Description
    AOJ-35 series wrist blood pressure monitor is designed as a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg. The device also has low voltage indication, which will be triggered when the battery is low. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device.
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    K Number
    K202173
    Device Name
    Pulse Oximeter
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2020-12-07

    (126 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen AOJ Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
    Device Description
    The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.
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