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Found 9 results
510(k) Data Aggregation
K Number
K231310Device Name
Electronic Blood Pressure Monitor
Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.
Date Cleared
2023-10-27
(175 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jumper Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic 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 at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
Device Description
The Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor, comprised of the host machine and the wrist cuff. It can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can store 199 groups of measurement data for two users.
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K Number
K182871Device Name
Mini TENS Therapy Device
Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.
Date Cleared
2019-08-01
(293 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jumper Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Device Description
Not Found
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K Number
K182495Device Name
Electronic Blood Pressure Monitor
Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.
Date Cleared
2019-03-03
(173 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jumper Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic 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 at medical facilities or at home.
Device Description
JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: 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 proposed JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The main differences are product appearance. 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.
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K Number
K172795Device Name
Infrared Thermometer
Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.
Date Cleared
2018-03-14
(180 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jumper Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
Device Description
The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments 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, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .
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K Number
K170965Device Name
Fingertip Pulse Oximeter
Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd.
Date Cleared
2017-11-03
(217 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jumper Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fingertip Pulse Oximeter JPD-500F is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Device Description
Not Found
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K Number
K140582Device Name
FINGERTIP PULSE OXIMETER
Manufacturer
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
Date Cleared
2014-08-28
(175 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JPD-500A Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Device Description
The JPD-500A fingertip pulse oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital.
The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, very easy to use it.
Principle of the fingertip pulse oximeter as follows:
A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.
Operation principle of the instrument:
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.
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K Number
K131457Device Name
FETAL ULTRASONIC MONITOR AND ACCESSORIES
Manufacturer
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
Date Cleared
2014-01-24
(249 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fetal Doppler JPD-100B is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
Device Description
JPD-100B Fetal Doppler is device prescribed by a licensed physician for use in hospitals and the homecare environment. It is a hand-held, battery powered audio Doppler device integrated with 2.5 MHz probe, used for detecting fetal heart beats. And the device is for prescription use and is intended for use at or after 12 weeks gestation.
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K Number
K131243Device Name
NON-CONTACT INFRARED THERMOMETER
Manufacturer
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
Date Cleared
2013-11-12
(195 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-conact Infrared Themometer, model JPD-FR 100, can measure for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Device Description
The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicated device KI-8280, use the same detection principle to measure the patient's temperature.
The subject device also use the focusing design to collect the infrared emitted from nearby area of patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature.
The compact, small and light-weight design, the Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
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K Number
K110124Device Name
FETAL DOPPLER JPD-100S
Manufacturer
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
Date Cleared
2011-02-04
(17 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
Device Description
JPD-100S Fetal Doppler is a prescription from licensed physician in hospitals, clinics and private offices. It is a hand-held, battery powered audio Doppler device integrated with 3MHz probe, used for detecting fetal heart beats. And the device is normally applied to pregnancy for more than twelve weeks.
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