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Found 16 results
510(k) Data Aggregation
K Number
K250470Device 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
880.2910Why 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
K250161Device 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
870.1130Why 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
K244000Device Name
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
Manufacturer
Shenzhen AOJ Medical Technology Co., LTD
Date Cleared
2025-04-30
(125 days)
Product Code
DXN
Regulation Number
870.1130Why 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 and diastolic 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
The 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.
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K Number
K250116Device Name
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd
Date Cleared
2025-04-24
(98 days)
Product Code
DXN
Regulation Number
870.1130Why 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 and diastolic 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
Arm blood pressure monitor, models(models ARM-30H, ARM-30J, ARM-30K and AOJ-90B), are designed as a battery driven automatic no-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. All the models included in this submission follow the similar software, same measurement principle and same specifications. All the models can be used with one cuff size 22~42 cm (8.6~16.5 inches). AOJ90B has extra 4G network except for other models.
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K Number
K232989Device Name
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd
Date Cleared
2024-07-01
(283 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why 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 home and healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
Device Description
The Pulse Oximeter is a battery powered device in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). 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 m, which is red light; the other is 905 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. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. There are five models AOJ-70A, AOJ-70C, AOJ-70E. Only AOJ-70E. Only AOJ-70D have wireless connection function via Bluetooth®. The device is a spot-check pulse oximeter and does not intended for life-supporting or life-sustaining.
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K Number
K232128Device 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
880.2910Why 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
K222994Device 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
870.1130Why 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
K221039Device 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
880.2910Why 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
K222125Device 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
870.1130Why 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
K221170Device 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
880.2910Why 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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