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510(k) Data Aggregation

    K Number
    K180714
    Device Name
    Probe Covers for Thermometers
    Manufacturer
    K-jump Health Co., Ltd.
    Date Cleared
    2018-09-24

    (189 days)

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

    K-jump Health Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
    Device Description
    The Probe Covers for Thermometers, which made of PE and EVA, are used for thermometers as barriers during oral or rectal temperature measurements. The Probe Covers are suitable for varied thermometers and non-sterilized packaging. A sandwich structure which is formed by the top and back paper and middle films.
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    K Number
    K170262
    Device Name
    Digital Thermometer
    Manufacturer
    K-Jump Health Co., Ltd.
    Date Cleared
    2017-09-28

    (244 days)

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

    K-Jump Health Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Thermometer is intended to measure oral temperature of human body. It can be used in home environment or at a doctor's clinic. It is indicated for use by people of all ages.
    Device Description
    The Digital Thermometer consists two parts. The thermometer probe part is a compact, small, light-weight, and battery-powered unit with thermometer sensor for oral temperature measurements. The thermometer probe must be connected to a compatible mobile phone device through its headphone jack for displaying measured temperatures. The mobile application could be conducted for operation and display temperature measurement when the Digital Thermometer connects with mobile device. The mobile application can be conducted on iOS operating system and Android operating system of mobile device. The mobile application could perform the functionality on mobile device screen including measurement activity, historical data activity, trend activity, basic setting and initial setting activity.
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    K Number
    K141505
    Device Name
    BASAL DIGITAL THERMOMETER
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2014-08-26

    (81 days)

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

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Basal Digital Thermometer is intended to measure the human body temperature for children and adults, especial for woman. It has precise digital display and be used in household environment and doctor in clinics as reference.
    Device Description
    Not Found
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    K Number
    K121520
    Device Name
    ULTRASONIC NEBULIZER (MESH TYPE)
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2013-03-15

    (297 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.
    Device Description
    The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.
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    K Number
    K120711
    Device Name
    NON-CONTACT THERMOMETER
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2012-11-19

    (256 days)

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

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-contact Thermometer is intended to measure the human body temperature for children and adults without contact to human body. It can be used by consumers in household environment and doctor in clinics as reference.
    Device Description
    The Non-contact Thermometer is a compact, small and light-weight device, which is powered by a battery and can be connected to a smartphone through headphone jack, for detecting body temperature without contact to human body. The measured temperature will be displayed on the screen of a smartphone.
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    K Number
    K103617
    Device Name
    DIGITAL FOREHEAD THERMOMETER
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2011-04-04

    (115 days)

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

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.
    Device Description
    The Digital Forehead Thermometers, Model KD-2201 & KD-2210, consist of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature.
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    K Number
    K102947
    Device Name
    NON-CONTACT INFRARED THERMOMETER
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2011-02-25

    (144 days)

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

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Contact Infrared Thermometer, Model KI-8280, can measure body temperature 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 KI-8280, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the objects, 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 predicate device, JXB Thermoflash, 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 object surface. This mechanism make the subject device have the ability to detect the object surface temperature in the distance of 3-8cm. 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 K-jump Health Co, Ltd. Non-Contact Infrared Thermometer, Model KI-8280, enables to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.
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    K Number
    K092335
    Device Name
    PEAK EXPIRATORY FLOW METER, KN-9710
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2010-04-09

    (248 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-jump Health Co, Ltd. Peak Flow Meter, Model KN-9710, is intended for monitoring expiratory-breath function at home under direction of a physician or licensed health care professional. It measures the peak expiratory flow (PEF) and timed forced expiratory volumes over 1 second (FEV1). This device can be used from 6-year-old children to adult patients for monitoring and managing of chronic respiratory conditions, especially asthma and COPD.
    Device Description
    The Peak Flow Meter, KN-9710, uses hot wire on the thin film inside the air flow measurement tube. The hot wire will electrically heat up to a constant temperature. As air flow passes through the air flow measuring tube, the wires cool off, requiring extra electrical energy to heat up to the the constant temperature. The air flow sensor will instantly feed back a voltage to maintain temperature. And the proper proportion and evaluation of the peak flow rate and volume will be determined. The KN-9710 is a compact, small and light-weight designed portable handheld device that electronically measures the Peak Expiratory Flow (PEF) as will as the Forced Expiratory Volume in the first second of expiration (FEV1).
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    K Number
    K092806
    Device Name
    AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2009-10-09

    (28 days)

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

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KP-7770 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff wrapped around the arm. It is indicated for use in adults. The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
    Device Description
    The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
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    K Number
    K083256
    Device Name
    ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Date Cleared
    2009-06-26

    (234 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    K-JUMP HEALTH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-jump Health Co., Ltd. Ultrasonic Nebulizer System includes a DC powered ceramic resonator and a fan that provides a source of mist for home health care use. The device is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
    Device Description
    The KN-9210 uses the ultrasound vibration technique in which a piezeoelectric ceramic installed as a generator of ultrasound wave when powered key pressed and system been powered on. The medicine solution on the semi-oval cup can be converted to mist through the water medium which propagated the ultrasound from resonator on the device. Then, a mini fan on the device drives the mist or aerosol through the air flow chamber and mouth piece installed on the top cover to the patient. The patient can use this aerosol for his/her respiratory therapy with two-safety valve installed on the mouthpiece which is standed on the top of drug ampoule. The device consists of a piezeoelectric ceramic, a fan, a plastic body (including a top cover, a main body, a rear cover, an inlet filter, a filter cover, a nebulization chamber and an air-flow chamber), a medicine cup, a printed circuit board with electronic components, a DC socket, an AC adapter power source (or a rechargeable battery assembly as an optional power source), and a key for ON/OFF operation.
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