Modius Lean

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 17, 2025 Neurovalens Limited Jason Mckeown CEO 8 Carmagrim Road Portglenone, County Antrim BT44 8BP United Kingdom Re: DEN240076 Trade/Device Name: Modius Lean Regulation Number: 21 CFR 876.5984 Regulation Name: Cranial electrotherapy stimulator for weight management Regulatory Class: Class I Product Code: SFW Dated: December 18, 2024 Received: December 18, 2024 Dear Jason Mckeown: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Modius Lean, a prescription device under 21 CFR Part 801.109 with the following indications for use: Modius Lean is a non-invasive, home-use neurostimulation medical device intended to support weight management alongside diet and exercise, in adults aged 22 years and older, who have a Body Mass Index of $27\mathrm{kg} / \mathrm{m}^2$ and greater. FDA concludes that this device should be classified into Class I. This order, therefore, classifies the Modius Lean, and substantially equivalent devices of this generic type, into Class I under the generic name cranial electrotherapy stimulator for weight management. FDA identifies this generic type of device as: **Cranial electrotherapy stimulator for weight management.** A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and exercise. Devices in this classification use a low level of electrical current that is not intended to induce a seizure. Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} DEN240076 - Jason Mckeown Page 2 options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification. On December 18, 2024, FDA received your De Novo requesting classification of the Modius Lean. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the Modius Lean into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request, FDA has determined that, for the previously stated indications for use, the Modius Lean can be classified in class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks to health are headaches, dizziness, ear pain, tinnitus, nausea, thermal injury or electrical shock, skin irritation, and electromagnetic interference with other medical devices. These risks are considered low and can be mitigated with general controls. The cranial electrotherapy stimulator for weight management is subject to the general controls of the FD&C Act. Section 510(l) of the FD&C Act (21 U.S.C. 360(l)) provides that a class I device is not subject to the premarket notification requirements under section 510(k) of the FD&C Act unless the device is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. FDA has determined that the device does not meet these criteria and, therefore, premarket notification is not required for the device. Thus, persons who intend to market this device need not submit a premarket notification containing information on the cranial electrotherapy stimulator for weight management they intend to market prior to marketing the device, subject to the limitations on exemptions in 21 CFR 876.9. In addition, this is a prescription device and must comply with 21 CFR 801.109. Although this letter refers to your product as a device, please be aware that some granted products may instead be combination products. If you have questions on whether your product is a combination product, contact CDRHProductJurisdiction@fda.hhs.gov. Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C 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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) {2} DEN240076 - Jason Mckeown Page 3 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 FD&C Act; 21 CFR 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. A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday. As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order. For comprehensive regulatory information about medical devices and radiation-emitting products, 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). If you have any questions concerning the contents of the letter, please contact Jennifer Hu at 240-402-9598. Sincerely, KELLIE B. KELM -S for Michael J. Hoffmann Director OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health