The tariff classification of FreeFlow ankle-foot orthosis (AFO) from an undisclosed country

N351250 August 8, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9021.10.0090; 9817.00.96 Elizabeth Merritt Flexport Customs LLC 760 Market Street, 8th floor San Franciso, CA 94102 RE: The tariff classification of FreeFlow ankle-foot orthosis (AFO) from an undisclosed country Dear Ms. Merritt: In your letter dated July 11, 2025, you requested a tariff classification ruling on behalf of your client, Thorwear Inc. dba Elevate Movement. Additional information was received by email dated August 7, 2025. Samples were provided, examined and disposed of. Elevate FreeFlow Ankle-Foot Orthosis (AFO) is specially designed to help patients with drop foot and reduced dorsiflexion. It consists of a footplate and lateral-posterior strut made from carbon fiber, a calf cuff, a CoolFlow liner fitting into the interior of the cuff, and a calf strap equipped with a BOA® Fit System for one-handed donning and doffing. You explain that the FreeFlow AFO supports the position of the foot and ankle for individuals unable to do so independently. This support restores proper gait mechanics, enhances mobility, and improves stability and balance, thereby reducing the risk of falls. You state that by facilitating a more normal gait, supporting the lower limb, and helping maintain proper posture and alignment, the FreeFlow AFOs also minimize strain on muscles and joints - including the knees, hips, and back - which reduces pain and fatigue. The FreeFlow AFO is available in both right and left foot models and is fully adjustable. You claim that foot drop is a physical impairment and the FreeFlow AFO is specially designed as an ambulatory aid to assist individuals with foot drop. Any other use is speculative and fugitive. The FreeFlow AFO’s carbon fiber footplate limits excessive downward movement of the forefoot (plantar flexion) while managing weight distribution and energy transfer during walking. A laterally positioned carbon fiber strut connects the footplate to the calf cuff, enhancing stability and preventing excessive inward (inversion) or outward (eversion) turning of the ankle. The calf cuff and strap secures the AFO to the upper part of the lower leg, ensuring it fits properly to provide the prescribed sagittal-plane dorsiflexion support, while the CoolFlow liner enhances comfort to support extended wear. You explain that the design, materials, cost, and warranty of the FreeFlow AFO make it overwhelmingly more beneficial and probable for use by individuals with permanent or chronic foot drop, as opposed to those with acute or transient cases. You state that Elevate is a recognized manufacturer of articles for the handicapped. Elevate’s marketing and sales channels are targeted to individuals suffering from foot drop and clinicians treating individuals with foot drop and Elevate works closely with healthcare providers and rehabilitation specialists to ensure that their products reach those who need them most. The FreeFlow AFO must be prescribed by a medical provider and are not available to the general public. They are covered by insurance. The FreeFlow AFO IFU states that the product “is to be used exclusively for orthotic fittings of the foot and ankle” and “(t)his product must be prescribed and fitted by a certified healthcare professional.” Elevate is the importer of record and consignee for imports of these products and controls the distribution of them. The applicable subheading for the FreeFlow AFO will 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 March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings 9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition to subheading 9021.10.0090, HTSUS, listed above. 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 from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e., 9903.01.25, in addition to subheading 9021.10.0090, HTSUS, listed above. However, the additional duties imposed by subheadings 9903.01.24 and 9903.01.25 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. Based on the information supplied, the FreeFlow AFO does satisfy the five factors set out by CBP. As a result, it is the opinion of this office that a secondary classification will apply in 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) James Forkan Acting Director National Commodity Specialist Division