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510(k) Data Aggregation
K Number
K231595Device Name
Electric Breast Pump
Manufacturer
Shenzhen Changkun Technology Co., Ltd.
Date Cleared
2023-10-26
(147 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Changkun Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts.The device is intended for a single user.
Device Description
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K Number
K221798Device Name
Finger Pulse Oximeter, Model: X1906P
Manufacturer
Shenzhen Changkun Technology Co., Ltd.
Date Cleared
2023-05-04
(317 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Changkun Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.
Device Description
The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user. Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit. The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.
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K Number
K193386Device Name
Wrist Electronic Sphygmomanometer
Manufacturer
Shenzhen Changkun Technology Co., Ltd.
Date Cleared
2021-01-27
(418 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Changkun Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wrist Electronic Sphygmomanometer is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Device Description
The Wrist Electronic Sphygmomanometer is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the oscillometric technique.
The device uses the oscillometric method to determine blood pressure. This is accomplished by means of a sensitive transducer, which measures cuff pressure and minute pressure oscillations within the cuff. The first determination sequence initially pumps up to a cuff pressure of about 180-230mmHg for adults. After inflating the cuff, the Wrist Electronic Sphygmomanometer begins to deflate it at a rate of 3-6 mmHq/sec, and measures systolic, mean, and diastolic pressure. The Wrist Electronic Sphygmomanometer deflates the cuff one step each time it detects two pulsations of relatively equal amplitude ("peak matching"). The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Wrist Electronic Sphygmomanometer is unable to find any pulse within several seconds, it will deflate to the process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances accuracy.
The device will obtain the pressure point, which is before the maximum peak and whose amplitude of peak is 0.45 times the reference amplitude, is determined to be the systolic pressure; and the pressure point, which is after the maximum peak and whose amplitude of peak is 0.75 times the reference amplitude, is determine to be the diastolic. When the diastolic pressure has been determined, the NIBP Meter finishes deflating the cuff and updates the screen.
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K Number
K193253Device Name
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
Manufacturer
Shenzhen Changkun Technology Co., Ltd.
Date Cleared
2020-06-17
(212 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Changkun Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer (model: CK-T1501, CK-T1503) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Device Description
Infrared Thermometer (model: CK-T1501,CK-T1502,CK-T1503) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when meas ure from 3-5 cm of the subiect's forehead with no contact.
lt uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
It composed by a measuring sensor, PCB, 4 buttons, a LCD and an enclosure. The functions of the three models are similar. The functions of "Temperature Alarm Point", "Temperature Offset", and "Warning Tone Switch" can be set. When measuring body temperature, users need to measure in body mode from 3-5 cm from their forehead. Press the measuring key, after 0.5 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 15 sec. The No. and stored value of the stored data are displayed at the bottom of the LCD screen. Press "+" / " -" to view the previous or next stored data, it can store 32 sets of measurements.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
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