The tariff classification of an ankle foot orthosis from Lithuania

N353591 October 3, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9021.10.0090; 9817.00.96 Gracia Plascencia Aspen Medical Products 6481 Oak Canyon Irvine, CA 92618 RE: The tariff classification of an ankle foot orthosis from Lithuania Dear Ms. Plascencia: In your letter dated September 10, 2025, you requested a tariff classification ruling. Aspen M2 Advanced Ankle Foot Orthosis (AFO) is used to provide support (stabilization and positioning) to the foot and ankle. It is available in both anterior and posterior configurations and different sizes, for both the right and left foot. It's designed to help conditions that affect walking and mobility, such as foot drop and neurological disorders. The M2 AFO can also help with conditions like spasticity, which causes increased muscle tone and stiffness, affecting normal gait. It consists of a footplate and lateral-posterior strut made from carbon fiber and a pad with straps. The weight limit is 220 pounds. It is required to be prescribed and adjusted by a physician as measurements, physical examination, and device modification will be needed depending on the patient’s foot size. The M2 AFO is specifically designed to facilitate a normal gait; its function is so specific that it cannot be used by the general public without having to be altered depending on the patient’s foot and leg size. The M2 AFO is sold directly from Aspen to physicians and medical device distributors. The applicable subheading for the Aspen M2 Advanced AFO will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[o]rthopedic appliances …: [o]rthopedic or fracture appliances, and parts and accessories thereof: [o]ther.” The general rate of duty will be free Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of the European Union with an ad valorem (or ad valorem equivalent) rate of duty under column 1-General less than 15 percent will be subject to an additional ad valorem rate of duty of 15 percent minus the column 1-General duty rate. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.02.20, in addition to subheading 9021.10.0090, HTSUS, listed above. However, the additional duties imposed by subheading 9903.02.20 shall not apply to goods for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and 9802.00.60. 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: “[a]rticles 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: [o]ther.” 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. As established in NY ruling N351250, dated August 8, 2025, the FreeFlow AFO, specially designed as an ambulatory aid for individuals with foot drop, qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. Given that the Aspen M2 Advanced AFO is almost identical to the FreeFlow AFO and serves the same purpose, this office finds that the Aspen M2 Advanced AFO will also qualify for a secondary classification under subheading 9817.00.96, HTSUS. The tariffs and additional 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/. 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) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division