RE: The tariff classification of a Recording Head Component from Germany

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N364324 September 1, 2026 CLA-2-90:OT:RR:NC:N3 135 CATEGORY: Classification TARIFF NO.: 9021.90.8100; 9817.00.96 Samantha Pate Synchron Corp 399 Sands Street Brooklyn Navy Yard, Building 303 Brooklyn, NY 11201 RE: The tariff classification of a Recording Head Component from Germany Dear Ms. Pate: In your letter dated August 14, 2026, you requested a tariff classification ruling. Additional information was provided via email dated August 21, 2026. The product under consideration is the Recording Head Component, also referred to as the Sensor and known as the Stentrode, of the Stentrode Brain-Computer Interface (BCI) System. The Stentrode BCI System is designed to detect neural activity associated with a user’s intended movements or commands and transmit those signals to an external digital device, enabling hands-free operation for individuals with severe paralysis or motor impairment. The system allows users to control devices such as a phone, tablet, or other digital interface without relying on voluntary muscle movement. The BCI system is intended to restore functional capabilities for individuals with severe motor impairment resulting from neurological conditions such as stroke, spinal cord injury, or amyotrophic lateral sclerosis. It functions as an implantable neuroprosthetic system that translates neural activity into digital commands, enabling users to communicate and interact with external devices. In this way, the system is intended for clinical use or clinical investigation to improve the ability of individuals with significant disability to communicate and interact with their environment. The device does not treat or cure the underlying neurological disease or injury. Rather, it is intended to provide functional assistance by compensating for lost motor function. The complete Stentrode BCI System consists of the Recording Head Component, the Implantable Recording and Transmitting Unit or IRT, also referred to as the receiver, and the Signal Processing Unit or SPU. The Recording Head Component consists of a self-expanding nitinol wire-mesh, stent-like frame embedded with a series of electrodes. This component is implanted in a blood vessel near the brain to detect neural signals with sufficient signal fidelity. It records brain activity and transmits those signals to the IRT. The IRT is
implanted in the patient’s chest and receives signals from the Recording Head Component. The IRT then transmits the signals by Bluetooth to the SPU for further processing. The SPU receives and processes the brain signals from the IRT before sending the processed commands to an external device, such as a phone, tablet, or other digital interface. The Recording Head Component is packaged in plastic tubes to protect its integrity during transport from Germany to the United States. After importation, it is connected to the remainder of the finished device through a series of cables. The applicable subheading for the Recording Head Component will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Other: Other.” The general rate of duty will be free. In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: Other.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. The Stentrode BCI System is designed specifically for individuals with permanent or severe motor disabilities. It does not treat or cure the underlying neurological condition, but provides functional assistance
by enabling users to control external digital devices. The system quantifies for duty-free treatment under subheading 9817.00.96, HTSUS, as an article specially designed or adapted for the use or benefit of the handicapped persons. The Recording Head Component is a component part of the system, fabricated to custom specifications, and is not usable for any other purpose. Accordingly, the Recording Head Component is also eligible for duty-free treatment under subheading 9817.00.96, HTSUS, free of duty and exempt from the Merchandise Processing Fee (MPF). The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 [email protected]. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division