The Allive 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "ALLIVE," a transcutaneous electrical nerve stimulator (TENS) intended for the prophylactic treatment of episodic migraine. It focuses on demonstrating substantial equivalence to a predicate device (CEFALY® K160237) rather than providing specific performance data against defined acceptance criteria from a clinical trial of the ALLIVE device itself.

Therefore, many of the requested details about acceptance criteria, performance data, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data provenance cannot be extracted from this document, as the submission relies on non-clinical testing and a clinical evaluation report based on the predicate device's clinical data.

Specifically, the document states on page 12: "Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (Allive) is not applied with clause b.6) of 21CFR882.5981." and "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Study Proving Device Meets Criteria

The document does not detail specific acceptance criteria for the ALLIVE device's clinical performance, nor does it present a clinical study of the ALLIVE device itself. Instead, it argues for substantial equivalence based on technical comparisons and a review of the predicate device's clinical data.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria for ALLIVE's Clinical Performance: Not explicitly stated in this document for the ALLIVE device. The submission relies on demonstrating substantial equivalence to a predicate device.
Reported Device Performance: No clinical performance data specific to the ALLIVE device is reported in this document. The document states, "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not applicable/not provided for a clinical study of the ALLIVE device. The "test set" here refers to non-clinical tests (biocompatibility, electrical safety, performance, usability, software).
Data Provenance: Non-clinical test data was generated for the ALLIVE device by the manufacturer (Nu Eyne Co., Ltd., Korea). The clinical evaluation references "collected clinical data of the predicate device," but specific provenance (e.g., country of origin, retrospective/prospective) for that predicate data is not detailed in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information pertains to medical imaging or diagnostics, where expert review establishes ground truth. The ALLIVE device is a therapeutic TENS device. Its performance is evaluated through technical specifications and indirectly through the predicate device's clinical outcomes.

4. Adjudication method for the test set

Not applicable. As above, this typically applies to expert review processes for diagnostic accuracy, not physical device performance or therapeutic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/imaging device. No MRMC study was conducted or referenced for the ALLIVE device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a TENS unit, not an algorithm. Its performance is inherent to its physical operation and effect on the patient.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests (electrical, biocompatibility, etc.), the "ground truth" is adherence to established international standards (e.g., IEC 60601-1, ISO 10993-5/10) and manufacturer's SOPs, verified through laboratory testing.
For the clinical evaluation, the ground truth would have been derived from the outcomes data of the predicate device's clinical trials, as summarized in the Clinical Evaluation Report, which is not provided in detail here beyond its existence.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2019

Nu Eyne Co., Ltd % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 Kr

Re: K192773

Trade/Device Name: Allive Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC, Dated: September 26, 2019 Received: September 30, 2019

Dear Dongha Lee:

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Timothy Marjenin 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192773

Device Name

ALLIVE (MODEL: ALLIVE01, AD-01)

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Nu Eyne. The logo features a stylized eye with the letters "NE" inside the pupil. Below the eye, the words "Nu Eyne" are written in a sans-serif font. Underneath the company name is the tagline "Advanced Vision Care, New Life."

510(k) SUMMARY

This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: SEPTEMBER 26, 2019

1. INFORMATION

1.1 Submitter Information

트 Submitter Name: Nu Eyne Co., Ltd.
. Address
- : #403, Seoul Biohub, 117-3 Hoegi-ro, Dongdaemun-gu, Seoul, 02455, Korea
. . Telephone Number: +82-2-6953-8120 Fax: +82-303-347-0017
I Email: dongseong.lee@nueyne.com

1.2 Contact Person

. Name: DongHa Lee (Consultant / KMC, Inc.)
. Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea
Telephone Number: +82-70-8965-5554 ■ Fax: +82-2-2672-0579
. E-mail: dhlee@kmcerti.com

2. DEVICE INFORMATION

2.1 Trade Name / Proprietary Name: ALLIVE (Model: ALLIVE01, AL-2HP)
2.2 Common Name: Transcutaneous electrical nerve stimulator to treat headache
2.3 Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2.4 Product Code: PCC
2.5 Classification Regulation: 21CFR 882.5891
2.6 Device Class: Class II (Special Control)
2.7 Classification Panel: Neurology

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Nu Eyne. The logo features a stylized eye with a blue iris and a white pupil. Inside the pupil is a stylized "N" and "E". Below the eye is the text "Nu Eyne" in a sans-serif font. Below that is the text "RESTORING SIGHT WITH LIGHT THERAPY" in a smaller font.

3. PREDICATE DEVICE

Predicate Device
Manufacturer	CEFALY Technology
Device Name (Trade Name)	CEFALY®
510(k) Number	K160237

4. SUBJECT DEVICE DESCRIPTION

5. INTENDED USE

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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo for NuEyene. The logo features a stylized eye with a blue outline and a stylized "N" inside the eye. Below the eye is the text "NuEyene" in a sans-serif font, with the tagline "Innovative ocular drug delivery" written in a smaller font below the company name.

6. SUBSTANTIAL EQUIVALENCE

Items	Subject Device	Predicate Device	Comparison Result
Manufacturer	Nu Eyne Co., Ltd.	CEFALY Technology	Different
Device	Stimulator, Nerve, Electrical,Transcutaneous, For Migraine	Stimulator, Nerve, Electrical,Transcutaneous, For Migraine	Same
Trade/Device Name	Allive	CEFALY®	Different
K Number	None	K160237	Different
Regulation Number	21CFR 882.5891	21CFR 882.5891	Same
Regulation Description	Transcutaneous electrical nervestimulator to treat headache	Transcutaneous electrical nervestimulator to treat headache	Same
Regulatory Class	Class II	Class II	Same
Product Code	PCC	PCC	Same
Definition	Used to apply an electrical currentto a patient's cranium throughelectrodes placed on the skin.	Used to apply an electrical currentto a patient's cranium throughelectrodes placed on the skin.	Same
Review Panel	Neurology	Neurology	Same
Physical State	Electrical stimulation unit withleads and cutaneous electrodes.	Electrical stimulation unit withleads and cutaneous electrodes.	Same
Technical Method	Applies an electrical currentthrough electrodes on patient'sskin.	Applies an electrical currentthrough electrodes on patient's skin.	Same

Target Area	Afferent cranial nerves.	Afferent cranial nerves.	Same
Intended use	The Allive is indicated for theprophylactic treatment of episodicmigraine in patients 18 years ofage or older.	The Cefaly® device is indicated forthe prophylactic treatment ofepisodic migraine in patients 18years of age or older.	Same
Picture	Image: Allive device	Image: Cefaly device	Different
Power Source	1rechargeable Lipo 3.7 V battery	1rechargeable Lipo 3.7 V battery	Same
Channels	1	1	Same
Computerized	Yes	Yes	Same
S/W provided	1 fixed program	1 fixed program	Same
Constant current	Yes	Yes	Same
Constant voltage	No	No	Same
Max output current	16mA	16mA	Same
Max output voltage (2kOhm)	32 Volts	32 Volts	Same
Patient Override Control Method	On/Off button	On/Off button	Same
	Max Leakage Current	None (battery operated)	None (battery operated)	Same
	Electrode	Self-adhesive	Self-adhesive	Same
	Indicator display: Unit functioning	Yes	Yes	Same
	Low battery indicator	Yes	Yes	Same
	Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304ISO 10993-1ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304ISO 10993-1ISO 10993-5ISO 10993-10	Same
	Timer Setting	Yes	Yes	Same
Device	Weight	110.2g	12g	Different
	Dimensions	160mm x 66.5mm x 55mm	55mm x 35mm x 15mm	Different
		Expected Service Life	5 years	7 years
		IP Classification	IP22	IP22
		Electrical Protection	Type BF	Type BF
	Battery Type	Lithium ion Battery	Lithium ion Battery	Same
Battery	Expected Service Life	7 years (300Cycles of completedischarge)	7 years (300Cylces of completedischarge)	Same
		Maximum input voltage(USB connector)	5.25 Vdc	5.25 Vdc
	Dimensions	94mm (W) x 30mm (H)	94mm (W) x 30mm (H)	Same
Electrode	Expected Service Life	20 times	20 times	Same
Special Requirement b.3) in accordance with 21CFR 882.5891
Waveform		Biphasic	Biphasic	Same
Maximum output voltage(V)	500 ohms	8	8	Same
	2,000 ohms	32	32	Same
	10,000 ohms	65	60	Same
Maximum output current(mA)	500 ohms	16	16	Same
	2,000 ohms	16	16	Same
	10,000 ohms	6.5	6	Same
Pulse duration (µS)		505	505	Same
Frequency Range		60Hz fixed	60Hz fixed	Same
Net charge (µC) per pulse		0	0	Same
Duration of the primary (depolarizing) phase(µS)		250	250	Same
Standby duration between the two phase (µS)		5	5	Same
Maximum current density(mA/cm2, r.m.s.)	500 ohms	2.37	2.37	Same
Maximum average power density(W/cm2)	500 ohms	0.000017	0.000017	Same
Maximum average current(Average absolute value, mA)	500 ohms	0.48	0.48	Same
Other Technical Item
Wave Shape		RectangularFull compensatedSymmetrical	RectangularFull compensatedSymmetrical	Same

Phase rise time		2 µS	2 µS	Same
Phase decay time		2 µS	2 µS	Same
Maximum Phase Charge (µS) at 500 ohms		4	4	Same
Modulation option	Amplitude	0 to 16 mA Fixed	0 to 16 mA Fixed	Same
	Frequency	60Hz fixed	60Hz Fixed	Same
	Duration	250 µS	250 µS	Same
Ramp Modulation	Ramp up	14min	14min.	Same
	Ramp down	45s	45s	Same
Steady time		6min	6min	Same
Session Duration		20min 45s	20min 45s.	Same
Amplitude modulation		Amplitude is adjusted by the user	Amplitude is adjusted by the user	Same
Material
Device housing materials		Plastic ABS	Plastic ABS	Same
Electrode top layer		Polyethylene terephthalate	Polyurethane	Different
Electrode intermediate layer		Conductive silver carbon ink	Carbon with silver coating	Different
Electrode bottom layer		Uv curable dielectric ink	x	Different
Central pin		N/A	N/A	Same
Metallic parts for magnetic attraction		Tinplate	Tinplate	Same

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo for Nu Eyne. The logo features a stylized eye with a blue outline and a white fill. Inside the eye is the letter "N" in a stylized font. Below the eye is the text "NU Eyne" in a sans-serif font, with the word "NU" in a larger font size than "Eyne".

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for NuEyene. The logo features a stylized eye with a blue outline and a stylized "N" inside. Below the eye is the text "NU Eyene" in a sans-serif font, with the word "NU" in a larger font size than "Eyene".

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Nu Eyne. The logo features a stylized eye with a blue outline and a stylized "N" inside. Below the eye is the text "Nu Eyne" in a sans-serif font. The text is in a dark color, possibly black or dark blue.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows a logo for NuEyene. The logo features a stylized eye with a blue outline and a white fill. Inside the eye is the letter "N" in a stylized font. Below the eye is the word "NuEyene" in a sans-serif font. Below the word "NuEyene" is the tagline "Technology for better vision, better life."

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for NuEyene. The logo features a stylized eye with the letters 'NE' inside the pupil. Below the eye is the text 'NuEyene' in a sans-serif font, with the tagline 'Advanced retinal imaging & telehealth' underneath in a smaller font.

7. NON-CLINICAL DATA

7.1 Safety Test
1. Biocompatibility

The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed in accordance with the following standards and FDA Guidance - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

No.	Test Items	Standards
1	Cytotoxicity	ISO 10993-5:2009
2	Sensitization	ISO 10993-10:2010
3	Intracutaneous Reactivity Test	ISO 10993-10:2010

2) Electrical Safety and EMC

The electrical safety tests were performed to protect patients from undue risks arise from any hazards associated with final device. The tests were performed in accordance with the following standards.

No.	Test Items	Standards
1	General requirement for basic safety andessential performance	IEC 60601-1:2005+A1: 2012(AAMI/ANSI ES 60601-1: 2005+A1: 2012)
2	General requirement for safety -Electromagnetic disturbances	IEC 60601-1-2:2014
3	General requirement for safety - Medicalelectrical equipment used in the homehealthcare environment	IEC 60601-1-11:2015 andFDA Guidance ("Design Considerations forDevices Intended for Home Use")
4	Particular requirement for safety - Nerveand muscle stimulators	IEC 60601-2-10:2012/Amd1:2016

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for Nu Eyne Advanced Spine and Joint Labs. The logo features a stylized eye with the letters "NE" inside the pupil. The text "Nu Eyne" is written below the eye, and the words "Advanced Spine and Joint Labs" are written in a smaller font below "Nu Eyne."

7.2 Performance Test

The following tests were performed to assess effectiveness of performance of the device. The tests were performed in accordance with following standards.

No.	Test Items	Standards
1	Particular requirement for safety – Nerveand muscle stimulators	IEC 60601-2-10:2012/Amd1:2016
2	Technical Test	Manufacturer's SOP

7.3 Usability V&V

The following tests were performed to assess effectiveness of usability of the device. The test was performed in accordance with following standards.

No.	Test Items	Standards
1	General requirement for safety - Usability	IEC 60601-1-6:2013IEC 62366-1:2015 andFDA Guidance ("Applying Human Factorsand Usability Engineering to MedicalDevices")

7.4 Software

The following tests were performed to assess effectiveness of software of the test was performed in accordance with following standards.

No.	Test Items	Standards
1	General requirement for safety -Programmable electrical medical systems(PEMS)	• IEC 62304:2006/Amd1:2015• FDA Guidance (“Guidance for the Contentof Premarket Submissions for SoftwareContained in Medical Devices”)

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for NuEyene. The logo features a stylized eye with the letters "NE" inside the pupil. Below the eye is the text "NuEyene" in a modern sans-serif font. Underneath "NuEyene" is the tagline "Innovative Intraocular Lens LLC" in a smaller font.

8. CLINICAL DATA

Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (Allive) is not applied with clause b.6) of 21CFR882.5981.

Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device.

In this evaluation report, the subject device is safe and effective as a treatment for headache in the indicated patient population.

The clinical evaluation was performed in accordance with following standards.

No.	Items	Standards
1	Clinical Evaluation	• MEDDEV 2.7.1. rev.4

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for NuEyene. The logo features a stylized eye with a blue outline and a teal fill. Inside the eye is the letter 'N' in white, with a curved line extending from the top of the 'N' to form the upper part of the eye. Below the eye is the word 'NuEyene' in a modern, sans-serif font, with the tagline 'Advanced Vision Patient Care LLC' in a smaller font underneath.

9. CONCLUSION

Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as general information, some technical and material information. Although there are some differences, the safety and performance test reports are supported to the safety and effectiveness of the subject device.

In this regard, we conclude that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.

(a)
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.(b)
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.