The Nerivio is indicated for acute treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.

Device Description

The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The Nerivio is identical to the previously cleared Nerivio device with a modification to the indications for use to allow treatment in patients aged 12 years and older.

The device is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware, LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included.

The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0- 40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, remaining number of treatments, and user notifications.

The patient is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

AI/ML Overview

The provided text describes a clinical study for the Nerivio device, indicated for acute treatment of migraine. However, it does not detail acceptance criteria in the typical format of a table with specific metrics and thresholds for a device's performance. Instead, it presents results of clinical endpoints related to safety and efficacy.

Based on the provided text, here's an attempt to structure the information according to your request, inferring acceptance criteria from the reported efficacy outcomes:

1. Table of "Acceptance Criteria" (Inferred from Efficacy Endpoints) and Reported Device Performance

Acceptance Criteria (Inferred from Efficacy Endpoints)	Reported Device Performance (Adolescent Study)
Primary Safety Endpoint:
Incidence of device-related adverse events	2.2% (1 participant)
Device-related serious adverse events	0% (None)
Withdrawal due to device-related adverse events	0% (None)
Secondary Efficacy Endpoints:
Proportion of participants achieving pain relief at 2 hours post-treatment (≥ mild to none, or severe/moderate to mild/none).	71.8% (28/39 participants)
Proportion of participants achieving pain-free at 2 hours post-treatment.	35.9% (14/39 participants)
Disappearance of associated symptoms (nausea/vomiting, photophobia, phonophobia) at 2 hours post-treatment.	Nausea: 54.5% (12/22)Photophobia: 41.9% (13/31)Phonophobia: 40.0% (10/25)
Exploratory Endpoints:
Sustained pain relief at 24 hours.	90.9% (20/22 participants)
Sustained pain-free at 24 hours.	90.9% (10/11 participants)
Improvement in functional ability at 2 hours.	69.7% (23/33 participants)
Improvement in functional ability at 24 hours.	69.0% (20/29 participants)
Within-subject consistency of pain relief (in at least 50% of treated headaches).	66.7% (26/39 participants)
Within-subject consistency of pain-free (in at least 50% of treated headaches).	33.3% (13/39 participants)
Reduction in Pediatric Migraine Disability Assessment (PedMIDAS) score.	Average decrease of 18.6 ± 23.4 (from 37.1±30.4 at enrollment to 18.5±26.8 at end of treatment phase).
System Usability Scale (SUS) score	Mean SUS score: 85.1±12.7 (high acceptability)

Note: The document does not explicitly state numerical acceptance thresholds. The "acceptance criteria" listed above are derived directly from the endpoints measured in the clinical study, implying that meeting these outcomes was considered sufficient for demonstrating safety and effectiveness for the expanded indication.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Final Analysis Set (Test Set): 39 participants (adolescents aged 12-17 years old) for efficacy endpoints. A total of 45 participants entered the treatment phase, and safety analyses were performed on all 45.
Number of treated migraine headaches: 159 qualifying migraine headaches.
Data Provenance: Prospective, open-label, single-arm, multicenter study conducted at 12 sites in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The study involved self-reported pain scores, absence/presence of migraine-associated symptoms, and functional disability recorded by participants using an electronic diary application. The ground truth for headache diagnosis (ICHD-3 criteria for migraine) would have been established by healthcare professionals at the study sites; however, the number and specific qualifications of these professionals are not detailed in the provided text. No independent expert panel was used for establishing individual case ground truth during the treatment phase as data was self-reported.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus by experts) is described for the patient-reported outcomes that formed the test set. The data was collected directly from participants via electronic diaries. For "missing data" for the primary efficacy endpoint, a worst-case scenario imputation was used, where all treatments with missing pain level data were considered failures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a single-arm study evaluating the device's effect in adolescents, not a comparative effectiveness study involving human readers assisting AI or comparing human performance with and without AI assistance. The device functions as a direct treatment, not an AI diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. Nerivio is a medical device that delivers electrical stimulation for migraine treatment, not an algorithm, so evaluation of "standalone (algorithm only)" performance is not relevant. The performance evaluated is that of the device in use by humans.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of the device was established based on:

Patient-reported outcomes: Self-reported pain scores (mild, moderate, severe, none), presence/absence of associated symptoms (nausea, photophobia, phonophobia), and functional disability (via electronic diary).
Validated questionnaire: Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire for migraine-related disability.
Safety data: Incidence and characteristics of adverse events reported by participants.

8. The Sample Size for the Training Set

The text does not refer to a "training set" in the context of machine learning, as this is a medical device for treatment, not an AI model. The study described is a clinical investigation to evaluate the device's safety and efficacy in a specific patient population (adolescents), thus acting as a validation study for the expanded indications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI model to which this question would apply. The "ground truth" for the device's intended use (migraine treatment) is established through clinical practice guidelines (ICHD-3 criteria for migraine diagnosis) and observed patient responses to treatment.

Summary

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January 22, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a blue square and the rest of the text in a smaller font size.

Theranica Bio-Electronics LTD % Janice Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103

Re: K203181

Trade/Device Name: Nerivio Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk and limb electrical stimulator to treat headache Regulatory Class: Class II Product Code: QGT Dated: October 26, 2020 Received: October 26, 2020

Dear Janice Hogan:

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

Sincerely,

Patrick Antkowiak Acting 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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510(k) Number (if known)

Device Name

Nerivio

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Theranica Bio-Electronics LTD.'s Nerivio

Submitter

Theranica Bio-Electronics LTD.

4 Ha-Omanut St. Netanya, ISRAEL, 4250438

Phone: +972-72-3909755

Facsimile: +972-72-3909762

Contact Person: Dagan Harris

Date Prepared: October 26, 2020

Name of Device: Nerivio

Common or Usual Name: Nerivio

Classification Name: Trunk and limb electrical stimulator to treat headache

Regulatory Class: Class II

Product Code: QGT

Predicate Device:

Device name: Nerivio

Manufacturer: Theranica Bio-Electronics LTD.

510(K) Number: K201824

Device Description:

The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile

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application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0- 40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, remaining number of treatments, and user notifications.

Intended Use / Indications for Use:

The Nerivio is intended for acute treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.

Summary of Technological Characteristics:

Both the subject device and the predicate device function as remote electrical neuromodulation (REN) devices that utilize electro-stimulation that relieves migraine headache, using equivalent output parameters. The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.

Characteristic	Subject Device	Predicate Device	Comparison
Submission Number		K201824	N/A
Device Name	Nerivio	Nerivio	Same
Manufacturer	Theranica Bio-ElectronicsLTD.	Theranica Bio-ElectronicsLTD.	Same
Indications for Use	The Nerivio is intended foracute treatment ofmigraine with or withoutaura in patients 12 yearsof age or older. It is aprescription use, self-administered device foruse in the homeenvironment at the onsetof migraine headache oraura.	The Nerivio is intended foracute treatment ofmigraine with or withoutaura in patients 18 yearsof age or older. It is aprescription use, self-administered device foruse in the homeenvironment at the onsetof migraine headache oraura.	Modified to12 years orolder
Prescription or OTC	Prescription	Prescription	Same
Electrical waveform	Biphasic rectangular,modulated	Biphasic rectangular,modulated	Same
Electrical outputMax output voltage500 Ω2 KΩ10 KΩ	20V (measured)60V (measured)60V (measured)	20V (measured)60V (measured)60V (measured)	Same
Characteristic	Subject Device	Predicate Device	Comparison
Max output current			Same
500 Ω	40 mA	40 mA
2 KΩ	30 mA	30 mA
10 KΩ	6mA	6mA
Maximum phase charge	8µC	8µC	Same
(500Ω)
Maximum averagecurrent (500Ω)	1.76mA	1.76mA	Same
Maximum currentdensity (peak) (500Ω)	1.6mA/cm2	1.6mA/cm2	Same
Maximum currentdensity (r.m.s) (500Ω)	0.34mA/cm	0.34mA/cm	Same
Maximum averagecurrent density (absvalue) (500Ω)	0.07mA/cm2	0.07mA/cm2	Same
Maximum averagepower density (500Ω)	1.41mW/cm2	1.41mW/cm2	Same
Frequency
Primary phase duration[µSec]	200	200	Same
Pulse Duration [µSec]	400	400	Same
Electrode Area	25 cm²	25 cm²	Same
Treatment location	Upper arm	Upper arm	Same
Treatment duration	45 min.	45 min.	Same
Reusable	Yes	Yes	Same
# of treatments per onedevice	12 treatments	12 treatments	Same
Power source	LiMnO2 cell battery	LiMnO2 cell battery	Same.
On/off button	Power push-button	Power push-button	Same
Dimensions	Device - 12.0x7.5x1.5 cmArmband - 48.0x10.0x0.3cm	Device - 12.0x7.5x1.5 cmArmband - 48.0x10.0x0.3cm	Same
Weight	Device - 50 grArmband - 33 gr	Device - 50 grArmband - 33 gr	Same
Shelf life	24 months	24 months	Same
Mobile Applicationsoftware	Yes	Yes	Same
Biocompatibility	Yes	Yes	Same
Sterile	No	No	Same
Processor control	Yes.	Yes	Same
Wireless control	Yes	Yes	Same
Automatic overload trip	Yes	Yes	Same
Automatic no load trip	Yes	Yes	Same
Automatic shut off	Yes	Yes	Same
Stimulation intensitycontrol	Yes	Yes	Same

Table 1 provides a comparison between the key functional features of the Nerivio and predicate device

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Table 1 – Comparison between Subject and Predicate Devices

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Performance Data:

Non-Clinical Tests:

Prior testing conducted on the cleared Nerivio (K201824) addressed verification of the hardware and software, as well as performance. The subject device is identical to the cleared Nerivio (K201824); therefore, the previously completed non-clinical tests remain applicable.

Clinical Investigations:

A clinical study of the Nerivio device in adolescents with migraine (ages 12-17 years old) was performed to assess the safety and clinical efficacy of Nerivio in adolescents with migraine. Specifically, it assessed the safety of the device, the capability of the Nerivio device to relieve migraine headache pain and associated migraine symptoms, and the tolerability to the Nerivio device in patients aged 12-17 years. The study was conducted in compliance with 21 CFR parts 50, 56. and 812.

The study was a prospective, open-label, single arm, multicenter study conducted at 12 sites in the USA. Eligible participants were adolescents (12–17 years old, inclusive) who met the International Classification of Headache Disorders (ICHD-3) criteria for migraine, all the inclusion criteria and none of the exclusion criteria.

Following a 4 week "run-in" phase, eligible participants were asked to treat 4 qualifying migraine attacks at home with their optimal stimulation intensity, as soon as possible after migraine headache began and always within one hour of attack onset, during a period of up to 8-week. Participants were instructed to avoid taking rescue medications prior or within the first two hours post-treatment. Pain scores, absence/presence of migraine associated symptoms, and functional disability were recorded at baseline, 2- and 24-hours post-treatment using the electronic diary application. Improvement in migraine-related disability following the treatment phase was assessed using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire.

The primary safety endpoint was assessed by the incidence of adverse events in general and by seriousness, severity and association to the device. Treatment tolerability was assessed by the percent of subjects who fail to complete the study because of adverse events.

The secondary endpoints were related to device efficacy and included the proportion of participants who achieved pain relief at 2 hours post-treatment, defined as improvement from severe or moderate pain to mild or none, or improvement from mild pain to none; proportion of participants who achieved pain-free (improvement from mild, moderate, or severe pain to none) at 2 hours, and disappearance of associated symptoms (nausealvomiting, photophobia, and phonophobia) at 2 hours post-treatment. Exploratory endpoints included sustained pain relief at 24 hours, sustained pain-free at 24 hours, and improvement in functional ability at 2 hours. Within-subject consistency of pain relief and pain-free responses, defined as the proportion of participants achieving pain relief/pain-free at 2 hours post-treatment in at least 50% of their treated headaches, were also assessed.

Among the 45 participants who entered the treatment phase, all participants completed at least one treatment (the training treatment) and 39 participants completed the test treatment, forming the final analysis set (two participants had missing data at 2 hours post-treatment, three participants did not have migraine headaches and one participant was a lost to follow-up).

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A total of 159 qualifying migraine headaches were treated with Nerivio for which pain data was recorded at baseline and at 2 hours post-freatment (average of 3.5 treatments per participant). Pain levels at baseline were 15.7% mild (25/159), 48.4% moderate (77/159) and 35.8% severe (57/159).

Safety analyses were performed on all 45 participants who used the device at least once. 10 participants (22.2%) reported at least one adverse event. There was one device-related adverse event reported (2.2%) in which a temporary pain in the arm was felt. This adverse event was mild and resolved after the treatment without requiring medication or any other intervention. The other adverse events which were deemed unrelated to the device included common cold (1 participant), chest congestion (2 participants), influenza (2 patient), streptococcus pharyngitis (1 participant), and upper respiratory infection (1 patient suffered from a migraine attack that was not treated by the device where the migraine presented as severe and the patient was treated in the ER \ There were no device-related serious adverse events and none of the participants withdrew from the study due to device-related adverse events.

The efficacy endpoints were conducted on the test treatment of the final analysis set of 39 participants. Pain relief and pain-free at 2 hours were achieved by 71.8% (28/39) and 35.9% (14/39) participants, respectively. For the primary efficacy endpoint, missing data was imputed using a worst-case scenario, in which all treatments with missing pain level data were considered failures. According to this sensitivity analysis, pain relief was achieved by 68.3% (28/41) of the participants.

Pain relief was sustained for 24 hours in 90.9% (20/22) of the participants, and pain freedom was sustained for 24 hours in 90.9% (10/11) of the participants (only subjects achieving relief/reedom at 2 hours were included in the analyses; 6 participants did not report pain level at 24 hours and were thus excluded from the analysis). Nausea, photophobia disappeared at 2 hours in 54.5% (12/22), 41.9% (13/31), and 40.0% (10/25) participants, respectively. Furthermore, 69.7% (23/33) participants experienced improvement in functional ability at 2 hours (only participants with functional disability at baseline were included in the analysis) and 69.0% (20/29) participants experienced improvement in functional ability at 24 hours (only participants with functional disability at baseline were included in the analysis; 4 participants with missing data at 24 hours were excluded from the analysis).

In order to assess long-term response to the treatment, a consistency analyses was conducted across all treated attacks (excluding the training treatment). This analysis demonstrated that 66.7% (26/39) of the participants experienced pain relief in at least 50% of their treated attacks, and 33.3% (13/39) of the participants experienced pain-free in at least 50% of their treated attacks.

Headache disability as determined by the impact of recurrent headaches on a patient's quality of life was assessed using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire. 42 participants who completed the questionnaire both at baseline and at the end of treatment phase were included in the analysis. The change between the PedMIDASs at enrollment (37.1±30.4) and the end of the treatment phase (18.5±26.8) was 18.6 ± 23.4. These results indicate that treating migraine headaches with Nerivio significantly decreases migraine disability. Interestingly, the average decrease observed in the current study is similar to the reduction shown for migraine preventive treatments in the pediatic population [21]. These findings suggest that Nerivio is effective for improving patients' quality of life.

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The perceived usability of Nerivio was assessed using the system usability scale (SUS). 42 participants who completed the questionnaire at the end of treatment phase were included in the analysis. The mean SUS score was 85.1±12.7. These results indicate high levels of acceptability, ease of use, learnability and confidence when using Nerivio.

The results of the study show that Nerivio is safe and effective for the acute treatment of migraine in adolescents.

Conclusions:

The Nerivio has the same intended use and similar indications (with the addition of adolescent users), technological characteristics, and principles of operation as its predicate device. The minor differences in the indications do not alter the intended therapeutic use of the device and do not affect its safety and effectiveness when used as labeled. Performance data demonstrate that the Nerivio is safe and effective for acute treatment of migraine in adolescents as it is in adult patients.

Regulation Number and Section

§ 882.5899 Trunk and limb electrical stimulator to treat headache.

(a)
Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including the typical sensations experienced during treatment;
(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
(iii) A shelf life for the electrodes and reuse information; and
(iv) Instructions on care and cleaning of the device.