N352290

N352290 August 29, 2025 OT:RR:NC:N3:135 CATEGORY: Origin Stephen Chan CEFALY US Inc. 19 Old Kings Hwy S., Suite 200 Darien, CT 06820 RE: The country of origin of a CEFALY Enhanced Kit (SKU 10701) Dear Mr. Chan: In your letter dated August 11, 2025, you requested a country of origin ruling on a CEFALY Enhanced Kit (SKU 10701). Additional information was submitted via email dated August 20, 2025. The CEFALY Enhanced kit (SKU 10701) is intended for both the acute treatment and preventive therapy of migraines in adults. SKU 10701 is similar to SKU 10801, previously ruled on in NY Ruling N351106, dated July 31, 2025. However, SKU 10701 does not include Bluetooth connectivity. The imported kit includes one main device (CEFALY Enhanced), a charging dock, three reusable adhesive electrodes, a resealable electrode bag, a USB charging cable, a plastic carrying case, user manuals, quick start guide, and packaging. The CEFALY Enhanced (main device) generates a treatment signal that is sent to stimulate and desensitize the trigeminal nerve. The user applies a reusable adhesive electrode to the forehead and attaches the main device magnetically. Upon activation, the device delivers mild electrical pulses to the ophthalmic branch of the trigeminal nerve. The main device consists of a top cover, a button cover, a rubber button, a plastic switch, a main printed circuit board assembly (PCBA), a battery, a flex PCBA assembly, a conductive spring, two flex PCB mountings, two t-shape magnets, a conductive metal part, a EVA upper side, left side, and right side of battery, a back housing, and a device label. The electrodes are made in Taiwan. The charging dock, cable, carrying case, and remaining items of the kit are made in China. The PCBAs of the main device are manufactured and programmed with firmware in Taiwan. This firmware, developed in Belgium, enables the therapeutic functionality of the device. It governs the main device operation, which is the defining purpose of the product. The firmware upload transforms the inert hardware into an operational medical device. The PCBA production process in Taiwan includes: Mounting of electrical components onto the two sides of the main PCB and flex PCBs via Surface Mount Technology (SMT) Verifying component placement and solder quality on the populated boards using Automated Optical Inspection (AOI) system Integrating the main board and flex board into a single assembly Loading firmware into the memory of the main PCBA Testing Storing completed PCBAs pending shipment Production process in China: The PCBAs of the main device are transported to China, where they are assembled into the final housing. This step includes connecting the PCBA to a rechargeable battery, integration with the mechanical button and enclosure, and final enclosure sealing and packaging. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Based on the information presented, the functionality of the CEFALY Enhanced (main device) is driven by its main PCBA and flex PCBA, which are manufactured in Taiwan. The assembly of the PCBAs and programming operations performed in Taiwan substantially transform the individual components into a product of Taiwan. The assembly process performed in China does not constitute a complex and meaningful operation, and therefore, does not result in a substantial transformation of the main device. As such, the country of origin of the CEFALY Enhanced (main device) will be Taiwan. The CEFALY Enhanced kit will be classified as a set per General Rule of Interpretation 3 (b) and the main device will impart the essential character of the set. Accordingly, the country of origin of the kit for duty purposes will be Taiwan. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division

is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Based on the information presented, the functionality of the CEFALY Enhanced (main device) is driven by its main PCBA and flex PCBA, which are manufactured in Taiwan. The assembly of the PCBAs and programming operations performed in Taiwan substantially transform the individual components into a product of Taiwan. The assembly process performed in China does not constitute a complex and meaningful operation, and therefore, does not result in a substantial transformation of the main device. As such, the country of origin of the CEFALY Enhanced (main device) will be Taiwan. The CEFALY Enhanced kit will be classified as a set per General Rule of Interpretation 3 (b) and the main device will impart the essential character of the set. Accordingly, the country of origin of the kit for duty purposes will be Taiwan. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to