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The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter. The electrodes placement in IceCap Product line is done accordingly to the 10/20 system. The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors. IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.

Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired.

The Delphi MCS Electrode Cap is made of elastic textile material, preserving the shape and size. The cap provides the exact position of the electrodes on the head without the need for additional measurements and adjustments. Large holes are provided for ventilation and access to the electrodes and patient's skin. The cap is fixed to the head with a chinstrap. The Cap is available in the following sizes: XL 60-66cm, XL/L 57-63cm, L 54-60cm, L/M 51-57cm, M 48-54cm. The textile caps sizes are identifiable by the color material or seam and marking according to international system 10-20. The Ag/AgCl electrodes are designed to provide minimal polarization and long-term stability of the signal. The conductive surface of the electrodes which is housed inside the electrode base does not have direct skin contact; an electrically conductive substance (hydrogel) is used inside the electrode base for improved conductivity. Delphi Cap electrodes are thin cup Ag/AgCl sintered electrode for EEG recording. The electrodes are designed for maximum comfort while the patient in a supine position. The design of this electrode is suitable for conducting combined TMS-EEG studies. The Ag/AgCl sintered electrode material guarantees minimum polarization and long-term signal stability, as well as an increased electrode life.

The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin. Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate). Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.

Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation. Through the Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction. Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device. Wave Electrode is available in two different models: Mod. AE02-50, with notch filter centred on the 50 Hz frequency; Mod. AE02-60, with notch filter centred on the 60 Hz frequency

The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The CAIs Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals. It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAIx and CAI software of CAI Monitoring System. The CAIs sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable. Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box. The hydrogel used in the sensors is designed for single use by one patient.

This is an EEG electrode set intended for routine clinical settings where rapid placement of a large number of EEG electrodes is desired. Patient population from infants up to any age.

WaveGuard™ Net EEG cap consists of Saline-based EEG electrolyte- soaked sponge electrodes made of PU substrate plated with Ag and arranged in Chin-strap (placed under the chin). Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/10, 10/20 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from baby to large adult head-size, spanning a total of 6 different cap sizes.

The Grass MR Conditional/CT Cup Electrodes and Arrays are 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 non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.

Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe. The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.

The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

Wrap Accessory Electrodes with GMX-ABSBELT01、GMX-ABSBELT02、GMX-WRIST01、 GMX-ELBOW01、GMX-LEG 01、GMX-ANKLE01、GMX-KNEE01、GMX-FOOT PAD 01、 GMX-GLOVES 01、SHOULDER01、GMX-NCK01, are intended to be used with legally Marketed transcutaneous electrical nerve stimulators or powered muscle stimulators which could be used in place of traditional cutaneous electrode patches. The different series of model means different placement of the Wrap Accessory Electrodes. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.

Glide is to be used exclusively for exoprosthetic fittings of the upper limb.

Glide is a surface electromyography (EMG) electrode and control system intended to be used with an upper limb prosthesis. Glide detects surface EMG signals using IBT Electrodes V2 placed on the user's skin. These signals are processed by Glide and are used to drive the upper limb prosthesis. Glide is compatible with industry standard domes. Glide does not have any direct skin contacting parts. Glide is compatible with most hands, wrists, and elbows that accept industry standard inputs. Glide accepts power from the prosthesis batteries and outputs control signals to hands, wrists, and other prosthetic components. The components of Glide are assembled into the prosthesis by a certified prosthetist or trained technician according to the individual needs of the amputee. Glide is a reusable single patient use device. Glide does not replace or modify any functionality of connected prosthetic components. Adjustments to the Glide components can be performed through Bluetooth data transfer using the IBT Control Application. The IBT Control Application runs on the iPad OS platform and allows the prosthetist to adjust the settings of the system, such as assignment of input filtered signal to prosthesis movements, adjustment of gains, etc. Glide components: - Core2 Controller (90010) - Output Cable (90020-XX) - IBT Remote Dome Electrodes (upto 8) - Electrode Cables - IBT Control Application - Core2 Fabrication Kit (94001) - Documentation - Dome Fabrication Kit (optional)

Amydi-med Disposable Non-invasive EEG Sensor is applied directly to an adults/pediatrics patient's skin to record physiological signals (e.g., the electroencephalogram, EEG) in the healthcare facility / hospital.

Amydi-med Disposable Non-invasive EEG Sensor is a low impedance, single patient use, disposable, non-sterile provided sensor that is designed for application to the sites including forehead, temporal, above eyebrow, and mastoid process. It is designed to provide ease of use and accurate electrode placement. The main components of this sensor are the flexible PCB with electrodes, polyethylene base pad with medical grade pressure sensitive adhesive on its double sides, nylon plastic tine disks, polyurethane foam disks, aqueous gel ( , and cable connector. Each sensor has three (3) to six (6) electrodes on the flexible PCB for different application sites.