(90 days)
No
The device description focuses on hardware components like electrodes, electronic circuitry with a microcontroller and firmware, and a Bluetooth radio for communication with a mobile application. The mobile application controls stimulation intensity and displays device status, without mention of adaptive learning, predictive analytics, or complex decision-making processes that would require an AI model. Additionally, there are explicit "Not Found" mentions for "Mentions AI, DNN, or ML" and descriptions of training/test sets often associated with AI model development.
Yes
The device is indicated for the acute and/or preventive treatment of migraine, which directly describes a therapeutic application to alleviate or prevent a medical condition.
No.
The device description and intended use clearly state that Nerivio is a treatment device, delivering electrical pulses to alleviate migraine symptoms, not to diagnose a condition.
No
The device is not a software-only medical device because the description explicitly states the devices are "wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices" that include physical components like electrodes, electronic circuitry (microcontroller, LED, power button, Bluetooth radio, battery), and an armband. While it is controlled by a mobile application software, there are significant hardware components that deliver the therapeutic effect.
No.
The device is a therapeutic device that delivers electrical pulses for migraine treatment; it does not perform diagnostic testing on in vitro samples.
N/A
Intended Use / Indications for Use
Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment.
Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment.
Product codes
QGT
Device Description
The Nerivio and Nerivio Infinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.
The devices are composed of:
- A pair of UltraStim electrodes (K130987) covered with hydrogel and removable protective film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable.
- An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
- An armband that is wrapped over the device to secure the device position on the user's arm is also included.
The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40 mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level (when connected to Nerivio Infinity), remaining number of treatments (when connected to Nerivio), and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and Nerivio Infinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
8 years of age or older
Intended User / Care Setting
self-administered device for use in the home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: Non-clinical testing was not needed to support this new 510(k) notice.
Clinical Information: The revision to the precaution about long term use to remove a precaution statement that the long term effects of chronic use of the device are unknown was supported by post market studies of real world data on use of Nerivio collected from US patients (Synowiec A, et. al. Adv Ther. 2024 Jan;41(1):170-18). The revision to the precaution about the use of Nerivio during pregnancy to remove the statement that the device has not been evaluated for use in pregnant women and add a new precaution that users should consult their HCP if they are pregnant or intend to get pregnant prior to using the device was supported by a retrospective survey-study published in literature (Peretz A, et. al. Headache. 2023;63(7):968-970).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Nerivio and Nerivio Infinity
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Theranica Bio-Electronics Ltd
℅ Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market St. Floor 23
Philadelphia, Pennsylvania 19103
Re: K250405
Trade/Device Name: Nerivio; Nerivio Infinity
Regulation Number: 21 CFR 882.5899
Regulation Name: Trunk And Limb Electrical Stimulator To Treat Headache
Regulatory Class: Class II
Product Code: QGT
Dated: February 12, 2025
Received: February 13, 2025
May 14, 2025
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K250405 - Janice Hogan Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K250405 - Janice Hogan Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250405
Device Name: Nerivio; Nerivio Infinity
Indications for Use (Describe)
Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment.
Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment.
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)
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:
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"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."
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510(k) SUMMARY
Theranica Bio-Electronics Ltd.'s Nerivio and Nerivio Infinity
Submitter:
Theranica Bio-Electronics Ltd.
4 Ha-Omanut St. Netanya 4250438, Israel
Phone: +972-72-3909755
Facsimile: +972-72-3909762
Contact Person: Dagan Harris
Date Prepared: May 14, 2025
Name of Device: Nerivio; Nerivio Infinity
Common or Usual Name: Nerivio; Nerivio Infinity
Regulation Name: Trunk and limb electrical stimulator to treat headache
Regulation Number: 21 CFR 882.5899
Product Code: QGT
Regulatory Class: Class II
Predicate Device: Nerivio; NerivioInfinity, Theranica Bio-Electronics Ltd. (K241756)
Predicate Device Regulation Number: 21 CFR 882.5899
Predicate Device Product Code: QGT
Predicate Device Regulatory Class: Class II
Device Description
The Nerivio and Nerivio Infinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.
The devices are composed of:
-
A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable.
-
An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
-
An armband that is wrapped over the device to secure the device position on the user's arm is also included.
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K250405
Page 2 of 6
The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40 mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level (when connected to Nerivio Infinity), remaining number of treatments (when connected to Nerivio), and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and Nerivio Infinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.
Intended Use / Indications for Use
Nerivio and Nerivio Infinity have identical indications for use, as follows:
The [Nerivio / Nerivio Infinity] is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment.
There have been no changes to the indications for use compared to the predicate device, other than a minor change in the name of Nerivio Infinity (from one word to two words).
Summary of Technological Characteristics
The technological characteristics of the subject Nerivio and Nerivio Infinity are nearly identical to those of the predicate Nerivio and Nerivio Infinity (K241756), and the principles of operation are the same. Both the subject devices and the predicate devices function as remote electrical neuromodulation (REN) devices that utilize electrostimulation that relieves migraine headache, and/or reduces the number of migraine days (depends on the treatment regime), 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.
There are a few minor technological differences between the subject and predicate devices:
- The subject Nerivio Infinity includes a near field communication (NFC) tag for authentication of the electrodes prior to treatment initiation.
- The mobile application was updated to enhance the user interface, incorporate support for the new NFC tag, support new versions of mobile operating systems, remove support of old operating systems, and implement bug fixes.
- An alternate coating for the armband was introduced for supply chain resiliency.
These minor technological changes could not significantly effect the safety or effectiveness of the device, and do not raise different questions of safety or effectiveness compared to the predicates. Table 1 provides a comparison between the key features of the subject devices and predicate devices.
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Table 1. Comparison between Subject and Predicate Devices
| Characteristic | Subject Device | Predicate Device (K241756) | Comparison |
|---|---|---|---|
| Nerivio | Nerivio Infinity | Nerivio | |
| Indications for Use | Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment. | Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment. | Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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 for acute treatment, or every other day for preventive treatment. |
| Prescription or OTC | Prescription | Prescription | |
| Number of channels | 1 | 1 | |
| Electrical waveform | Biphasic rectangular, modulated | Biphasic rectangular, modulated | |
| Max output voltage | |||
| 500 Ω | 20V (measured) | 20V (measured) | |
| 2 KΩ | 60V (measured) | 60V (measured) | |
| 10 KΩ | 60V (measured) | 60V (measured) | |
| Max output current | |||
| 500 Ω | 40 mA | 40 mA | |
| 2 KΩ | 30 mA | 30 mA | |
| 10 KΩ | 6 mA | 6 mA | |
| Maximum phase charge (500Ω) | 8 μC | 8 μC |
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| Characteristic | Subject Device | Predicate Device (K241756) | Comparison |
|---|---|---|---|
| Nerivio | Nerivio Infinity | Nerivio | |
| Maximum average current (500Ω) | 1.76 mA | 1.76 mA | |
| Maximum current density (peak) (500Ω) | 1.6 mA/cm² | 1.6 mA/cm² | |
| Maximum current density (r.m.s) (500Ω) | 0.34 mA/cm² | 0.34 mA/cm² | |
| Maximum average current density (abs value) (500Ω) | 0.07 mA/cm² | 0.07 mA/cm² | |
| Maximum average power density (500Ω) | 1.41 mW/cm² | 1.41 mW/cm² | |
| Frequency | Range: 100-120 Hz Average: 110 Hz (measured) | Range: 100-120 Hz Average: 110 Hz (measured) | |
| Primary phase duration | 200 μSec | 200 μSec | |
| Pulse duration | 400 μSec | 400 μSec | |
| Electrode area | 25 cm² | 25 cm² | |
| Treatment location | Upper arm | Upper arm | |
| Treatment duration | 45 minutes | 45 minutes | |
| Reusable | Yes | Yes | |
| # of treatments per device | 18 treatments per one entire device (device body and electrodes). | Up to 18 treatments for each pair of electrodes ("refill unit"). No limitation for device body. | 18 treatments per one entire device (device body and electrodes). |
| Power source | LiMnO2 cell battery (non-rechargeable) | Li-Ion cell battery (rechargeable) | LiMnO2 cell battery (non-rechargeable) |
| On/off button | Power push-button | Power push-button |
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| Characteristic | Subject Device | Predicate Device (K241756) | Comparison |
|---|---|---|---|
| Nerivio | Nerivio Infinity | Nerivio | |
| Dimensions | Device (including the electrodes): 12.0 x 7.5 x 1.5 cm Armband: 48.0 x 10.0 x 0.3 cm | Device body: 7.9 x 3.5 x 1.7 cm Refill unit: 13.7 x 7.6 x 5.3 cm Armband: 48.0 x 10.0 x 0.3 cm | Device (including the electrodes): 12.0 x 7.5 x 1.5 cm Armband: 48.0 x 10.0 x 0.3 cm |
| Weight | Device (including the electrodes): 50 g Armband: 33 g | Device body: 38 g Refill unit: 15 g Armband: 33 g | Device (including the electrodes): 50 g Armband: 33 g |
| Mobile application software | Yes | Yes | |
| Biocompatibility | Yes | Yes | |
| Sterile | No | No | |
| Processor control | Yes | Yes | |
| Wireless control | Yes | Yes | |
| Wireless technology | Bluetooth | Bluetooth and near field communication (NFC) | Bluetooth |
| Automatic overload trip | Yes | Yes | |
| Automatic no load trip | Yes | Yes | |
| Automatic shutdown | Yes | Yes | |
| Stimulation intensity control | Yes | Yes | |
| Remote (over-the-air) firmware update option | No | Yes | No |
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Performance Data
Non-Clinical Tests
Non-clinical testing was not needed to support this new 510(k) notice.
Clinical Information
The subject device includes revisions to the precautions in the device labeling regarding the effects of long-term use of Nerivio and Nerivio Infinity, and regarding device use during pregnancy. The revision to the precaution about long term use to remove a precaution statement that the long term effects of chronic use of the device are unknown was supported by post market studies of real world data on use of Nerivio collected from US patients (Synowiec A, et. al. Adv Ther. 2024 Jan;41(1):170-18). The revision to the precaution about the use of Nerivio during pregnancy to remove the statement that the device has not been evaluated for use in pregnant women and add a new precaution that users should consult their HCP if they are pregnant or intend to get pregnant prior to using the device was supported by a retrospective survey-study published in literature (Peretz A, et. al. Headache. 2023;63(7):968-970). The data reported on Nerivio is applicable to Nerivio Infinity due to the high degree of similarity and identical therapeutic outputs and controls between Nerivio and Nerivio Infinity.
Conclusions
The subject device has the same intended use, indications for use, and core technological characteristics and principles of operation as the previously cleared predicate device. The only differences between the subject and predicate devices are the change in labeling precautions regarding long-term use and use during pregnancy, and minor technological updates to limit the ability of users to overuse electrodes, provide greater flexibility for manufacturing the armband in the event of supply chain issues, and updates to the mobile app software for a smoother user experience, compatibility with the latest operating systems, and routine bug fixes. None of these changes results in a change in the device's overall purpose of treating and preventing migraine, nor do they raise different questions of safety or effectiveness. Thus, the subject device is substantially equivalent to cited predicate device.