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510(k) Data Aggregation

    K Number
    K192035
    Device Name
    EvaQMax Smoke Evacuation System
    Manufacturer
    Bio Protech, Inc.
    Date Cleared
    2019-08-29

    (30 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bio Protech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
    Device Description
    Not Found
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    K Number
    K152984
    Device Name
    Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2016-06-03

    (238 days)

    Product Code
    IKT, GXZ
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.
    Device Description
    The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage. The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
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    K Number
    K153019
    Device Name
    Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2016-03-21

    (158 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only. Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only. Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).
    Device Description
    Not Found
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    K Number
    K143103
    Device Name
    PROPENCIL Smoke Pencil
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2015-07-16

    (260 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
    Device Description
    PROPENCIL Smoke Evacuation pencil consists of two types of disposable Smoke Evacuation monopolar pencils with finger controlled button switch or rocker switch for cutting and coagulation, and also suction cap, tube, hose are all included. All products are sterile, single-use, and disposable. The method of sterilization is Ethylene Oxide. The finger controlled switch is push button or rocker switch and the blade is an uncoated stainless steel electrode or ceramic coated non-stick blade. PROPENCIL Smoke Evacuation pencil is designed to work with standard electrosurgical generators utilizing a 3-pin monopolar connection port and smoke evacuation units utilizing 8-to-22 hose connector. The tube is located near the electrode tip. PROPENCIL Smoke Evacuation pencil is available with either a push button or a rocker switch, and some models include an optional holster. Most importantly the suction cap can be replaced with longer ones to extend the length of smoke pencil. The PROPENCIL smoke evacuation pencil has a shelf-life of 36 months.
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    K Number
    K142099
    Device Name
    CUTANEOUS ELECTRODES
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2014-11-17

    (108 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
    Device Description
    Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
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    K Number
    K111270
    Device Name
    REUSABLE STIMULATING ELECTRODES
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2011-09-13

    (133 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals. Electrical stimulation current applications of these electrodes are: - Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a) - b) Electrical muscle stimulation (EMS) - C) Functional electrical stimulation (FES) - d) Microcurrent electrical nerve stimulation (MENS) - Interferential stimulation (IF) e) - f) Neuromuscular electrical stimulation (NMES)
    Device Description
    Reusable Stimulating Electrodes
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    K Number
    K100246
    Device Name
    MAX-IF1000
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2010-11-24

    (301 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
    Device Description
    MAX-IF1000 Interferential Stimulator
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    K Number
    K091248
    Device Name
    MAXEMS, MODELS 1000 AND 2000
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2009-11-30

    (216 days)

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

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Relax muscles 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis 6. Maintaining or increasing range of motion
    Device Description
    The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.
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    K Number
    K092732
    Device Name
    PROPENCIL ESU PENCIL
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2009-11-25

    (82 days)

    Product Code
    GEI, DEV
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROPENCIL ESU Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation.
    Device Description
    The PROPENCIL ESU pencil (and as also to be offered for sale under various private label trade names) is intended for standard electrosurgical operation such as cutting and coagulation. It is designed to work with standard electrosurgical generators. PROPENCIL consists of various types of disposable ESU pencils with hand controlled switch for cutting and coagulation. All of products are sterile device. The method of sterilization is Gamma sterilization. The hand controlled switch is pushbuttons or rocker button and the blade is an uncoated stainless steel electrode or non-stick coated stainless steel electrode.
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    K Number
    K092761
    Device Name
    PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
    Manufacturer
    BIO PROTECH, INC.
    Date Cleared
    2009-11-24

    (76 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO PROTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROPLATE is a disposable, single-use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.
    Device Description
    PROPLATE Electrosurgical Grounding Plate
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