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510(k) Data Aggregation

    K Number
    K243661
    Device Name
    Electronic Blood Pressure Monitor
    Manufacturer
    Hetaida Technology Co., Ltd.
    Date Cleared
    2025-02-07

    (72 days)

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

    Hetaida Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).
    Device Description
    Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm~32cm and cuff of size 22cm~42cm.
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    K Number
    K241202
    Device Name
    Electric nasal aspirator (HTD2601US)
    Manufacturer
    Hetaida Technology Co., Ltd.
    Date Cleared
    2024-07-01

    (62 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hetaida Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
    Device Description
    Electric nasal aspirator consists of main unit, and the suction portion working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
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    K Number
    K223170
    Device Name
    Electronic Blood Pressure Monitor, model: HTD6602US
    Manufacturer
    HeTaiDa Technology Co., Ltd.
    Date Cleared
    2023-12-05

    (420 days)

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

    HeTaiDa Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)
    Device Description
    Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm~32cm and cuff of size 22cm~42cm.
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    K Number
    K203332
    Device Name
    Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
    Manufacturer
    HeTaiDa Technology Co., Ltd.
    Date Cleared
    2021-02-25

    (105 days)

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

    HeTaiDa Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HeTaiDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.
    Device Description
    The HeTaiDa infrared body thermometer, Models HTD8818A,HTD8816C,HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient's forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.
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    K Number
    K200159
    Device Name
    Non-contact Infrared Body Thermometer, model:HTD8823US
    Manufacturer
    HeTaiDa Technology Co., Ltd.
    Date Cleared
    2021-01-05

    (349 days)

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

    HeTaiDa Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
    Device Description
    Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.
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    K Number
    K180387
    Device Name
    Infrared Ear Thermometer
    Manufacturer
    HeTaiDa Technology Co., Ltd.
    Date Cleared
    2019-01-10

    (332 days)

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

    HeTaiDa Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.
    Device Description
    Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal. The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will display on the device's LCD. The total operation takes less than 5 seconds.
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    K Number
    K171888
    Device Name
    Non-contact infrared body thermometer
    Manufacturer
    Hetaida Technology Co., Ltd
    Date Cleared
    2018-07-23

    (392 days)

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

    Hetaida Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.
    Device Description
    The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead. The thermometers HTD8818A, HTD8816C and HTD8808C infer temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The thermometer design consists lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature. This permits temperature measurement from a distance without contact with the object to be measured.
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    K Number
    K180385
    Device Name
    Infrared Body Thermometer
    Manufacturer
    HeTaiDa Technology Co., Ltd.
    Date Cleared
    2018-05-11

    (88 days)

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

    HeTaiDa Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.
    Device Description
    Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane. The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
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