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510(k) Data Aggregation

    K Number
    K112421
    Device Name
    EMG SUCTION UNIT
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2011-09-01

    (9 days)

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

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used to remove body fluids from a patient's airway or respiratory system. It is for use on the order of a physician only.
    Device Description
    The EMG Suction Unit is a compact medical suctioning device which can be powered by AC current (115V 60Hz) through the wall electric outlet at home. The vacuum pressure of the EMG Suction Unit is to be produced through a built-in vacuum pump which is consisted of an AC motor, a cylinder, a piston connecting rod, a cup seal, an eccentric crank, an inlet valve, an outlet valve, etc. When turn on the suction unit, the motor starts to run, its shaft drive the eccentric crank which actuates the piston connecting rod moving up and down in the cylinder. When the piston is being in the down stroke, a vacuum pressure is produced in the cylinder, then air will be suctioned into the cylinder through a one-way inlet port, when the piston is being in the up stroke, it pressed out the suctioned air through another one-way outlet port to the atmosphere, these two one-way ports avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When the motor keep running, a continuous vacuum pressure source through inlet port is produced. A set of plastic cover enclose the vacuum pump, wire harness, etc. to profect the user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a vacuum adjusting set, a vacuum meter and a device vacuum inlet port. The vacuum adjusting set is connected to the inlet port of the vacuum pump through inner tubing, the vacuum meter and the device vacuum inlet port are connected to the vacuum adjusting set through a three-way connector and inner tubing. Device's vacuum pressure can be adjusted by tuning the knob of the vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provides the vacuum pressure source. One end of a connection tubing is connected to a bacteria filter which is connected to the device vacuum inlet port, and the other end of the connection tubing is connected to a collection container. Furthermore, one end of a patient tubing is connected to the inlet port of the collection container, and the other end of the patient tubing is connected to an applied part (like suction catheter). Put the applied part to the adequate location of the patient body, then this device can start suctioning sputum or other body fluid.
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    K Number
    K072634
    Device Name
    EMG TRITON -COMP,MODEL NCA01-XXX SERIES
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2008-11-19

    (428 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.
    Device Description
    The EMG TRITON-COMP. Is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital use. It is capable of servicing nebulizers and humidifiers to produce particle aerosol mist. The EMG TRITON-COMP. Powered by AC current (115V 60Hz) through the wall electric outlet at home, Maximum constant working pressure at 50psi, delivering up to 22LPM of flow (at pressure 10psi) and does not need software to drive. The outlet compressed air pressure of EMG TRITON-COMP. is produced through a built-in compressor. The consist parts include motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve ----etc. When turns on the compressor, motor starts to run and its shaft drives the eccentric crank to actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down strike, a vacuum pressure is produced in the cvlinder, then the air will be sucked into the cylinder through an one-way inlet port. When the piston is being in the up strike, it presses out the air through the other outlet port to the atmosphere, these two one-way ports avoid the air being sucked from the atmosphere as well as the air in cylinder being pressed back to the inlet port. When motor keeps running, then the compressed air through outlet port is produced. One set of iron cover with protective earth encloses the compressor and wire harness to protect user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a compressed air pressure regulator, pressure gauge and air outlet port. The pressure regulator connected to the air outlet tube of compressor. The pressure gauge and the compressed air outlet port are connected to the pressure regulator through a three way connector and inner tube. Device's compressed air pressure can be adjusted by tuning the knob of pressure regulator, accuracy within +/-5%. The pressure gauge display the pressure data during operation.
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    K Number
    K063448
    Device Name
    EMG AC/DC SUCTION UNIT
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2006-11-30

    (15 days)

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

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a vacuum suction device. It is to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory. It is for use on the order of a physician only.
    Device Description
    The EMG AC/DC Suction unit is a compact medical suctioning device which can be powered by the AC current through a attached AC Adapter unit connecting to the wall electric outlet at home or DC power source through a set of built-in rechargeable battery or automobile DC 14V electric power through power cord connecting to the receptacle during transportation. The vacuum pressure of EMG AC/DC Suction unit is to be produced through a built-in vacuum pump which is consisted of DC motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve---etc parts. When turn on the suction unit, motor start to run, its shaft drive the eccentric crank which actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down stroke, a vacuum pressure is produced in the cylinder, then air will be suctioned into the cylinder through an one way inlet port, when the piston is being in the up stroke, it pressed out these suctioned air through another one way outlet port to the atmosphere, these two one way port avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When motor keep running, then a continuous vacuum pressure source through inlet port is produced. One set of plastic cover enclose the vacuum pump, control p. c. board, battery and wire harness to protect user from electrical shock and mechanical hurt hazard. Following components on the cover are to be the operating interface to the use: a power switch, a receptacle, a vacuum adjusting set, vacuum meter and device vacuum inlet port. The vacuum adjusting set through inner tubing connecting to the inlet port of vacuum pump, the vacuum meter and the device vacuum inlet port are connecting to the vacuum adjusting set through a three way connector and inner tubing. Device's vacuum pressure can be adjusted by tuning the knob of vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provide the vacuum pressure source. Connect the device vacuum inlet port, bacteria filter (Bacteria filter pore size: 0.2microns,Model:3928) and collection container with two PVC tubing respectively. then connect one end of a biocompatible patient tubing (comply with ISO10993 / material: PVC compound, Type: 3MSA060p3X) to the collection container inlet port, the other end of the patient tubing connected to the applied part (like drainage tubing). Put the applied part to the adequate location of patient body, then this device can start to carry out the suctioning sputum and other body liquid's operation.
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    K Number
    K062888
    Device Name
    MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2006-10-24

    (28 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Middle Wheel Drive Power Chair, CWD01 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K052438
    Device Name
    EMG HANDLE NEBULIZER NB02 SERIES
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2006-01-31

    (147 days)

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

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.
    Device Description
    The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.
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    K Number
    K043520
    Device Name
    EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2005-10-21

    (305 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.
    Device Description
    Not Found
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    K Number
    K043238
    Device Name
    COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2005-07-06

    (226 days)

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

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer used as prescribed by a physician for medication in the home or health care facility.
    Device Description
    The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer.
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    K Number
    K042349
    Device Name
    EMG MODEL SUA01 SUCTION UNIT
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2004-12-16

    (108 days)

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

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
    Device Description
    Not Found
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    K Number
    K033206
    Device Name
    EPW FOLDABLE POWER WHEELCHAIR, EPW-03
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2003-12-18

    (77 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    EPW Foldable Power Wheelchair, EPW-03
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    K Number
    K033204
    Device Name
    ESG 4-WHEEL SCOOTER, ESG-03
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2003-11-12

    (41 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMG TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restrict to a seated position.
    Device Description
    The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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