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510(k) Data Aggregation

    K Number
    K233098
    Device Name
    MYOTouch Muscle Stimulator
    Manufacturer
    SunMed LLC.
    Date Cleared
    2024-08-02

    (311 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SunMed LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
    Device Description
    MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.
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    K Number
    K222335
    Device Name
    Surgical Mask
    Manufacturer
    Luoyang Sunmed Devices Co., Ltd.
    Date Cleared
    2022-10-11

    (69 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Luoyang Sunmed Devices Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile/sterile.
    Device Description
    The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric. The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering. The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100. Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
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    K Number
    K121743
    Device Name
    EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
    Manufacturer
    SUNMED LLC
    Date Cleared
    2013-03-28

    (288 days)

    Product Code
    BXN, EAS
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.
    Device Description
    The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load). The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.
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    K Number
    K081805
    Device Name
    CUFFALERT
    Manufacturer
    SUNMED
    Date Cleared
    2008-11-14

    (141 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes. The CuffAlert™ is not intended to replacement clinical judgment.
    Device Description
    The CuffAlert™ is a simple in-line pressure monitor which contains a calibrated diaphragm which distends with increases in cuff pressure. One can set the maximum pressure limit from 10 to 40 cm H2O by rotating and locking a knob. Once set, it is placed on the pilot ballowing it to be in-line with the cuff. If the cuff exceeds the set pressure limit on the CuffAlert™ the diaphragm distends making contact with the battery, thus activating the red LED. The accuracy of pressure measurement has been determined to be +/- 2 cm H2O @ 10 cm H2O; +/- 3 cm H2O @ 20 - 30 cm H2O; and +/- 4 cm H2O @ 40 cm H2O.
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    K Number
    K062112
    Device Name
    SUNMED FOLEY CATHETERS
    Manufacturer
    SUNMED, INC.
    Date Cleared
    2007-06-04

    (315 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMED, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
    Device Description
    The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.
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    K Number
    K955631
    Device Name
    ORTHOPLUG HARD BONE DESIGN
    Manufacturer
    SUNMED, INC.
    Date Cleared
    1996-02-27

    (78 days)

    Product Code
    LZN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMED, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955632
    Device Name
    ORTHOPLUG SOFT BONE DESIGN
    Manufacturer
    SUNMED, INC.
    Date Cleared
    1996-02-27

    (78 days)

    Product Code
    LZN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMED, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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