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510(k) Data Aggregation

    K Number
    K242568
    Device Name
    Wrist Blood Pressure Monitor (OHMS11, OHMS12)
    Date Cleared
    2025-01-30

    (154 days)

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

    Shenzhen Zhongkeming**wang **Telecommunications Software Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm.
    Device Description
    The Wrist Blood Pressure Monitor is a reusable, active, non-sterile, non-invasive and non-implantable device for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This device has the systolic and diastolic display features. The device is of the watch type and powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 300mmHg. Product includes device (preinstalled with a strap and large-sized cuff: 16.6-21.0cm), strap with a medium-sized cuff: 13.0-16.5cm, wrist measuring tape, charging base (with the power cable). The product functional configurations of OHMS11 and OHMS12 are completely identical, and the difference between the two is reflected in the color (OHMS11 is the dark gray color, OHMS12 is the champagne color).
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    K Number
    K163201
    Device Name
    KYMCO EQ10D Scooter
    Date Cleared
    2017-03-16

    (121 days)

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

    K**WANG **YANG MOTOR CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The EQ10D scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop. This scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.
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    K Number
    K140239
    Device Name
    JIAWANG
    Date Cleared
    2014-06-12

    (133 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    JIA**WANG **GLOVE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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    K Number
    K130940
    Device Name
    KYMCO EQ20C SCOOTER
    Date Cleared
    2013-10-07

    (186 days)

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

    K**WANG **YANG MOTOR CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
    Device Description
    The EQ 20C scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
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    K Number
    K122102
    Device Name
    POWER FREE VINYL EXAMINATION GLOVES
    Date Cleared
    2013-09-09

    (420 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    **WANG **TONG XINGHUA CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Vinyl Examination Glove
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    K Number
    K122100
    Device Name
    POWDERED VINYL EXAMINATION GLOVES
    Date Cleared
    2013-08-22

    (402 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    **WANG **TONG XINGHUA CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powdered Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powdered Vinyl Examination Glove
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    K Number
    K111169
    Device Name
    PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
    Date Cleared
    2011-10-03

    (160 days)

    Product Code
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    K**WANG **MYUNG DAICOM INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.
    Device Description
    Not Found
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    K Number
    K082900
    Device Name
    KYMCO FORU, MODEL EQ10
    Date Cleared
    2008-10-28

    (28 days)

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

    K**WANG **YANG MOTOR CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ10 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K082901
    Device Name
    KYMCO FORU, MODEL EQ20
    Date Cleared
    2008-10-28

    (28 days)

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

    K**WANG **YANG MOTOR CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ20 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K081133
    Device Name
    KYMCO FORU, MODEL EQ40
    Date Cleared
    2008-06-10

    (50 days)

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

    K**WANG **YANG MOTOR CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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