Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

K212071 · Cefaly Technology · PCC · Dec 13, 2022 · Neurology

Device Facts

• Record ID: K212071
• Device Name: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
• Applicant: Cefaly Technology
• Product Code: PCC · Neurology
• Decision Date: Dec 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Cefaly Dual Series are small, portable, non-invasive transcutaneous electrical nerve stimulators worn on the forehead via self-adhesive electrodes. Devices deliver biphasic, rectangular, symmetrical, fully compensated electrical pulses to treat migraine. Users operate the device to select between two programs: acute treatment (100 Hz) or preventative treatment (60 Hz). Subject devices add Bluetooth connectivity for mobile app data display, RFID for electrode detection, and audio/visual indicators for status (e.g., low battery, connection). Devices are powered by a 3.7V LiPo battery and charged via a docking station. Output parameters (voltage, current, pulse width) remain identical to predicates. Healthcare providers or patients use the device to manage migraine symptoms; output affects clinical decision-making by providing a non-pharmacological treatment option. Benefits include migraine relief and prevention.

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and adhesive integrity testing. Technical parameters were fully characterized and validated against international standards.

Technological Characteristics

Transcutaneous electrical nerve stimulator; 3.7V LiPo battery; biphasic, rectangular, symmetrical, fully compensated waveform; 1 channel; 0-16 mA amplitude; 250 µs pulse width; 60/100 Hz frequency. Materials: acrylic hydrogel electrodes. Connectivity: Bluetooth. RFID for electrode detection. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10.

Indications for Use

Indicated for acute and preventative/prophylactic treatment of migraine with or without aura in patients 18 years of age or older.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population. (7) Labeling must include the following: (i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. (ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery. (iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown. (iv) A summary of the expected risks and benefits of using the device. (v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications. (vi) Information on how the device operates and the typical sensations experienced during treatment. (vii) A detailed summary of the device technical parameters. (viii) An expiration date/shelf life for the electrodes and the number of times they can be reused. (ix) Disposal instructions.

In combination with the general controls of the Food Drug & Cosmetic Act, the Transcutaneous Electrical Nerve Stimulator to Treat Headache is subject to the following special controls:

Predicate Devices

• Cefaly Dual (K173006)
• Cefaly Dual (K201895)

Submission Summary (Full Text)

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December 13, 2022

CEFALY Technology % Parul Chansoria CEO and Founder Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, Wyoming 82801

## Re: K212071

Trade/Device Name: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: January 6, 2022 Received: January 10, 2022

Dear Parul Chansoria:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani, MS MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K212071

Device Name

Cefaly Dual Series (Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx)

Indications for Use (Describe) 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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 5.1. Submitter's information

CEFALY Technology, LIEGE Science Park, Rue Louis Plescia, 34, 4102 Seraing, Belgium.

## Contact Person

Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: + 408-475-8091 E-mail: [e-mail]

Summary Prepared: December 12, 2022

#### 5.2. Device Information

- 5.2.1. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected OTC Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation Number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
- 5.2.2. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected Rx Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC

CEFALY Technology K212071

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- 5.2.3. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - OTC Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
- 5.2.4. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - Rs Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC

### 5.3. Predicate Device Information

The following Predicate Devices are used:

| Company | Product | 510(k)<br>Number | Subject Device |
|----------------------|--------------|------------------|-------------------------------------------------------------------------------|
| CEFALY<br>Technology | Cefaly® Dual | K173006 | • Cefaly® Dual<br>Connected Rx,<br>• Cefaly® Dual<br>Enhanced with<br>RFID Rx |
| CEFALY<br>Technology | Cefaly® Dual | K201895 | • Cefaly® Dual<br>Connected<br>OTC,<br>• Cefaly® Dual |

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| | | | Enhanced with<br>RFID OTC |
|--|--|--|---------------------------|
|--|--|--|---------------------------|

The Predicate Devices stated above are not subject to recall by the FDA.

#### 5.4. Device Description

Cefaly® Dual Series by CEFALY Technology consists of Cefaly® Dual Enhanced with RFID - R., Cefaly® Dual Enhanced with RFID - OTC. Cefaly® Dual Connected - R. and Cefaly® Dual Connected - OTC. The Cefaly® Dual Series of devices are identical to the Predicate Devices Cefaly® Dual - Rx (K173006) and Cefaly® Dual - OTC (K201895).

The submission includes CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected which are indicated for Ry, are identical to the Predicate Devices CEFALY® Dual - Rx (K173006) and CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected, which are indicated for OTC, are identical to the Predicate Devices CEFALY® Dual - OTC (K201895). Additionally, all the devices in the CEFALY® Dual Series 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 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.).

#### ર.ડ. Indications for Use

# 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

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## 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

### 5.6. Technological Characteristics

## 5.6.1. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:<br>Cefaly® Dual<br>Connected - OTC | Predicate<br>Device:<br>Cefaly® Dual | Equivalence | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | CEFALY<br>Technology | CEFALY<br>Technology | | |
| Device Name | CEFALY® Dual<br>Connected | CEFALY® Dual | - | |
| 510(k) Number | - | K201895 | - | |
| Product code | PCC | PCC | Equivalent | |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent | |
| Classification: | II | II | Equivalent | |
| Indications for<br>Use | The indications for<br>use of CEFALY®<br>Dual Connected for<br>an over-the-counter<br>use are: | The indications<br>for CEFALY®<br>Dual for an<br>over-the-counter<br>use are: | Equivalent | |
| | • Acute treatment<br>of migraine with<br>or without aura<br>in patients 18<br>years of age or<br>older<br><br>• Preventative<br>treatment of<br>migraine in<br>patients 18<br>years of age or<br>older | • The acute<br>treatment of<br>migraine with<br>or without aura<br>in patients 18<br>years of age or<br>older<br><br>• The prophylactic<br>treatment of<br>episodic<br>migraine in<br>patients 18<br>years of age or<br>older | | |
| Mobile<br>Application | Yes | No | Different | |
| Bluetooth | Yes | No | Different | |
| RFID for<br>electrode<br>detection | Yes | No | Different | |
| Charging System | Charging dock,<br>Power adapter and<br>USB Cable. | Power adapter<br>and USB Cable | Different | |
| Power Source | 1 rechargeable LiPo<br>3.7 V battery | 1 rechargeable<br>LiPo 3.7 V<br>battery | Equivalent | |
| Electrode Metal<br>Plate (RFID tag)<br>Thickness | 1 mm | 0.4 mm | Different | |
| Weight | 25 grams | 12 grams | Different | |
| Dimensions | 66 mm x 47 mm x 17 mm | 55 mm x 40 mm x<br>15 mm | Different | |
| Channels | 1 | 1 | Equivalent | |
| Treatment<br>Programs | 2 programs:<br>Program 1 - The acute treatment of migraine attacks Program 2 - The prevent treatment of migraine | 2 programs:<br>Program 1 - The acute treatment of migraine attacks Program 2 - The prophylactic treatment of episodic migraine | Equivalent | |
| Waveform | Biphasic | Biphasic | Equivalent | |
| Shape | Rectangular | Rectangular | Equivalent | |
| | Full compensated | Full compensated | Equivalent | |
| | Symmetrical | Symmetrical | Equivalent | |
| Net charge (µC)<br>per pulse | 0 | 0 | Equivalent | |
| Maximum output<br>voltage (V): | | | | |
| At 500 ohms | 8 | 8 | Equivalent | |
| At 2,000 ohms | 32 | 32 | Equivalent | |
| At 10,000 ohms | 60 | 60 | Equivalent | |
| Maximum output<br>current (mA): | | | | |
| At 500 ohms | 16 | 16 | Equivalent | |
| At 2,000 ohms | 16 | 16 | Equivalent | |
| At 10,000 ohms | 6 | 6 | Equivalent | |
| Pulse duration<br>(μs) | 505 | 505 | Equivalent | |
| Maximum Phase<br>Charge (µC) @<br>500 Ohms | 4 | 4 | Equivalent | |
| Type of<br>impedance<br>monitoring<br>system | Electrical | Electrical | Equivalent | |
| Maximum<br>current density<br>(mA/cm2, r.m.s.)<br>at 500 ohms | 2.37 | 2.37 | Equivalent | |
| Treatment Programs output specifications - Program 1 | | | | |
| Amplitude | 0 - 16 mA | 0 - 16 mA | Equivalent | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | | |
| Session duration | 60 minutes | 60 minutes | | |
| Maximum<br>average current<br>(average absolute<br>value, mA) at<br>500 ohms | 0.8 | 0.8 | Equivalent | |
| Maximum<br>average power<br>density (W/cm²)<br>at 500 ohms | 0.000047 | 0.000047 | Equivalent | |
| Treatment Programs output specifications - Program 2 | | | | |
| Amplitude | 0 - 16 mA | 0 - 16 mA | | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | Equivalent | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | | |
| Session duration | 20 minutes | 20 minutes | | |
| Maximum<br>average current<br>(average absolute<br>value, mA) at<br>500 ohms | 0.48 | 0.48 | Equivalent | |
| Maximum<br>average power<br>density (W/cm²)<br>at 500 ohms | 0.000017 | 0.000017 | Equivalent | |
| Audio-visual Indications | | | | |
| Audio Indicators<br>for low battery,<br>Acute and<br>Prevent Program<br>(Low Battery<br>Charge),<br>Intensity is<br>10mA, Increase<br>Intensity (For<br>Experienced<br>CEFALY Users),<br>Bluetooth<br>connection and<br>disconnection<br>and electrode<br>detection | Present | Absent | Different | |
| Visual Indicators<br>for low battery,<br>bluetooth<br>connection and<br>disconnection<br>and electrode<br>detection | Present | Absent | Different | |
| Electrode | | | | |
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent | |
| RFID tag | Present | Not Present | Different | |
| Electrode Metal<br>plate | 1 mm | 0.4 mm | Different | |
| (tinplate)<br>thickness | | | | |
| Electrode Gel<br>used | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent | |
| Packaging configuration | Gift Box | Made of cardboard,<br>has a magnetic latch,<br>artwork, and label. | A white box<br>made of<br>cardboard, no<br>magnetic latch<br>and no artwork.<br>The white box<br>slides inside a<br>sleeve that has<br>artwork and<br>label. | Different |
| | Storage Case | The storage case<br>contains a USB<br>cable, charging<br>dock, device, user<br>manual, Instruction<br>guide, and<br>resealable bag<br>consisting of<br>electrodes | The storage case<br>contains a USB,<br>charging adapter,<br>and electrode<br>inside.<br>The device is on a<br>cardboard sheet<br>on top of the<br>storage case. User<br>manual(s) are<br>below the case. | Different |
| Number of<br>electrodes<br>provided with the<br>device | | Three (3) | One (1) | Different |
| Electrode storage | Resealable bag | Non- resealable<br>bag | Different | |

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CEFALY Technology K212071

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CEFALY Technology K212071

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#### 5.6.1.1. Similarities between Subject Device and Predicate Device

- · The intended use is the same for the Subject and the Predicate Devices and both devices are meant for over-the-counter use.
- Treatment Programs Waveform characteristics and output . specifications are same for both the Subject and Predicate Device.
- The Channels are the same for both the Subject and . Predicate Devices.
- Maximum output voltage is the same for both Subject and . Predicate Devices.
- Maximum output current is the same for both Subject and . Predicate Devices.
- The Power source (Battery) is the same for both Subject . and Predicate Devices.
- . The Pulse duration, Maximum phase charge and Type of impedance monitoring system is the same for both Subject and Predicate devices.
- . The dimensions and patient contacting material used in the electrode is same for both Subject and Predicate devices.

#### Differences between Subject Device and Predicate Device 5.6.1.2.

- The usage of Mobile application and Bluetooth in Subject . Device is different from Predicate Device.
- The RFID tag is added to electrode for Subject Device for ● electrode detection and, electrode metal plate thickness in

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Subject Device (1mm) is different from Predicate Device (0.4mm).

- The weight and dimensions of the Subject device is ● different from Predicate Device.
- The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
- The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
- The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.

# 5.6.2. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:<br>Cefaly® Dual<br>Connected - Rx | Predicate Device:<br>Cefaly® Dual | Equivalence |
|--------------|---------------------------------------------------|-----------------------------------|-------------|
| Manufacturer | CEFALY<br>Technology | CEFALY<br>Technology | |
| Device Name | CEFALY® Dual<br>Connected | CEFALY® Dual | - |

CEFALY Technology K212071

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| 510(k) Number | - | K173006 | - |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications for Use | The indications for use of CEFALY® Dual Connected for an Rx are:<br><br>• Acute treatment of migraine with or without aura in patients 18 years of age or older<br><br>• Prophylactic treatment of migraine in patients 18 years of age or older | The indications for CEFALY® Dual for an Rx use are:<br><br>• The acute treatment of migraine with or without aura in patients 18 years of age or older<br><br>• The prophylactic treatment of episodic migraine in patients 18 years of age or older | Equivalent |
| Mobile Application…