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Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.

This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.

Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.

Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

TSI's Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes. They are supplied sterile, are non-pyrogenic, and are intended for single use only.

Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.

Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape.

Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.

The PressOn™ Electrode Headset is intended for use in the recording of electroencephalogram (EEG), evoked potential (EP), or as a ground and reference in an EEG or EP recording. The device is provided sterile for single patient use only.

The PressOn™ Electrode Headset is intended to be used in medical environments where quick EEG electrode application is required. The device provides a workflow solution where the availability of technologists or other specialty-trained EEG staff is limited for applying EEG electrodes. The headset comprises between 2 to 48 PressOn™ Electrodes, each loaded into individual button applicators, which are positioned in predetermined locations and interconnected by elastic netting, altogether forming the headset. The predetermined electrode positions are arranged by generally referencing the 10-20 Positioning System, but with flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, and other separate devices. Like the predicate, the subject device is minimally invasive and does not directly contact neural tissues. The PressOn™ Electrode Headset is placed on the patient's head and is oriented and secured using a nasion marker and chinstrap. The distal end of the device contains the array of PressOn™ electrodes in predetermined locations that are placed on the scalp by minimal insertion of the micro needles into the epidermis layer of the skin for use during monitoring procedures. The PressOn™ electrodes in the subject device are inserted in an identical fashion as the predicate device (K130220). Minor material and dimensional changes have been made to the original applicator to allow for multiple applicators to be connected to form the headset. At the proximal end of the subject device is a multipin connector where the electrode leadwires terminate. The multipin connector interfaces with color-coded extension cables (identical to those used in another previously cleared Rhythmlink device, reference device K172503) that terminate into single pin connectors, which are then connected to monitoring equipment. The leadwires are constructed of ribbon cable arrays with electrode attachment points at various distances based on the predetermined locations. These features are designed with the intent for quick application by non-neurological based medical personnel with signal quality equivalent to predicate device [K130220].

The DMS Disposable Subdermal Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

The DMS Disposable Subdermal Needle Electrodes are supplied sterile and intended for single use. This subdermal needle electrodes can be used to record the neurological and neurophysiological evoked potentials. The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals. The DMS Disposable Subdermal Needle Electrodes are supplied sterile.

E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into multi-paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

The MR Conditional PressOn™ Electrode is intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is provided sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.

The design of the Rhythmlink Disposable MR Conditional PressOn electrode is identical to the existing PressOn electrodes used to record neurological activity during electroencephalograph (EEG) and evoked potential (EP) procedures. The device consists of a disk shaped electrode with three sets of flat tyne or micro needles made from Nitinol. The Electrode is permanently attached to a leadwire which is 10cm (100mm) in length. An accessory cable is supplied to attach to the 10cm electrode leadwire to create a 1.0, 1.5, 2.0 or 2.5 meter traditional lengths during the Monitoring procedure. This accessory cable is labeled "MR Unsafe" and is NOT intended to be in the MR environment at any time. A significantly shorter lead wire of 10cm is permanently attached to the electrode and reduces the effects of matching the electrode leadwire length to the wave length of the RF component. This condition reduces the probability of matching the RF wave length to the leadwire length and reduces the likely hood of an increase in the heating effect. This will enable users to leave the electrodes in place during magnetic resonance imaging (MRI) procedures.