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The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.

The ELEXIR 2.0 is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.

Cefaly Connected - OTC is indicated for: - 1. Acute treatment of migraine with or without aura in patients 18 years of age or older - 2. Preventative treatment of migraine in patients 18 years of age or older Cefaly Connected - Rx is indicated for: - 1. Acute treatment of migraine with or without aura in patients 18 years of age or older - 2. Prophylactic treatment of migraine in patients 18 years of age or older

CEFALY Connected - Rx and CEFALY Connected - OTC consists of neurostimulators, Cefaly Electrodes, and mobile application. The neurostimulators are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraines similar to Cefaly® Dual Connected - Rx, and Cefaly® Dual Connected - OTC of K212071. The mobile application, CeCe Miqraine Management App, is a two-way communicatinq, mobile application, installed and run on users' personal mobile devices such as smartphone or tablet. The app is compatible with neurostimulators of CEFALY Connected devices (Rx and OTC). The mobile application communicates with the neurostimulator through Bluetooth and allows users to track the treatments.

The DOOPANG(YPS-301BD) is indicated for: - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.

This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally. The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).

The Milieve is indicated for - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Milieve device is a transcutaneous electrical nerve stimulator (TENS) developed for the acute treatment of migraine and the prophylactic treatment of episodic migraine. The device is placed on the patient's forehead to stimulate the upper branch of the trigeminal nerve. It is harmless to the human body. The Milieve device is indicated for OTC use. There are two treatment programs: ACUTE and PREVENT. The ACUTE treatment program is intended for treatment during migraine attack at the onset of a migraine. The PREVENT treatment program is meant for daily preventative treatment. The Mileve device comprises a plastic external casing and electrical components. It is operated by an internal rechargeable battery.

The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

TENS device-HeadaTerm 2 offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device- HeadaTerm 2 enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. The device could adhere to patient's forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.

Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for: 1. Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Preventative treatment of migraine in patients 18 years of age or older Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for: 1. Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Prophylactic treatment of migraine in patients 18 years of age or older

The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.). The devices are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.

The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The modified Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The modified Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches. The modified Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp. The modified Relivion® is powered by a rechargeable battery and the headset incorporates an onboard user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired. The modified Relivion® can communicate via a low energy Bluetooth link with the modified Relivion®'s dedicated mobile application on the patient's smartphone. The modified Relivion®'s mobile application is optional, and it is used by the patient to display the device status and provide indications and alerts. Additionally, the modified Relivion® mobile application also enables the patient to report their migraine headache status. The main modification introduced in the Relivion® Device compared to the cleared predicate device (K203419) is an added optional Physician Interface that enables physicians to remotely follow-up on the patient's migraine attacks status and the treatments they performed using the Relivion device, based on the data transferred to it via the modified mobile application. Both the modified Relivion®'s mobile application (for patients) and added physician interface (for physicians) are referred together as the optional "Patient Management Interface" (PMI) of the modified Relivion® Device.

THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older

The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.

Migraine TENS Digital Pain Reliever LT1103 - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older. Migraine TENS Digital Pain Reliever LT1103-P - The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area. The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity. The Migraine TENS Digital Pain Reliever consists of the following elements: - Main Device - Charging Station - Electrode Pads - USB cable

The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches. The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp. The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired. The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.