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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.

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 Cefaly® Dual 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 Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. The electrical impulses generated by the Subject Device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.

The Cefaly® Dual 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 Cefaly® Dual device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically. The electrical impulses generated by the Cefaly® Dual device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (VI). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.

Cefaly® Acute is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.

The Cefaly® Acute device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Cefaly® Acute is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 60 minutes.

The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Cefaly® device is a supraorbital transcutaneous nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes. The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates a sedative effect and is intended to treat migraine headaches.