CLA-2-90:OT:RR:NC:N3:135

Tyler Keith
Flexport Customs, LLC
100 California Street
San Francisco, CA 94111

RE: The tariff classification of foot prostheses and their individual components from Sweden

Dear Mr. Keith:

In your letter dated January 15, 2026, you requested a tariff classification ruling on behalf of your client, Lindhe Xtend Inc. A sample of a spectra sock was received, examined, and disposed of.

The products under consideration are three models of Lindhe “Xtend Foot prosthetics” or “Xtend Foot” (Xtend Foot Först, Xtend Foot Trenne, and Xtend Foot Fri) and their individual components. These foot prostheses share the same basic construction and components. A complete foot prosthesis consists of three parts: a fiber composite foot (which you termed “Foot Structure”), a foot shell, and a spectra sock (protective sock). Each Xtend Foot prosthesis can support patient weights up to 330 pounds and is available in seven sizes, ranging from 23 to 29 centimeters. The Xtend Foot Först features a 17° lateral flexion system that mimics the natural roll of the foot on uneven terrain. The Xtend Foot Trenne adds multi-axial articulation with 42° inversion/eversion, 25° dorsi/plantar flexion, and 6° transverse rotation — enabled by a tri-axial joint mechanism — and integrated bumpers that absorb shock and guide motion. The Xtend Foot Fri is designed for simplicity and freedom, offers a low build height, high lateral compliance, and sealed construction for use in water and rugged conditions.

The fiber composite foot for each of the three models of foot prostheses consists of a glass fiber forefoot laminate, a glass fiber heel laminate, a carbon fiber base laminate, and a titanium pyramid connector. It features a split-toe configuration. The titanium pyramid connector, located at the top of the foot, is used to secure it to a socket on the patient’s residual or prosthetic limb.

The Foot Shell for each of the three models of foot prostheses is the outer cover of the Xtend Foot. It is made from renewable, rubber-based materials and designed to resemble the shape and appearance of a natural human foot. It allows patients to wear ordinary footwear and maintains a discreet profile, while protecting the internal prosthetic components from dirt, moisture, and wear. The Foot Shell comes in right and left models to accommodate the fitting of the prosthesis inside a normal shoe and is compatible with all Xtend Foot prosthetic models and available in four colors and seven sizes, ranging from 23 centimeters to 29 centimeters, to match the size of the selected fiber composite foot.

The Spectra Sock for each of the three models of foot prostheses, available in three sizes, is a lightweight, knitted, protective sleeve made from ultra-high-molecular-weight polyethylene (UHMWPE) fiber and shaped to fit the fiber composite foot. Its top snugly encircles the pyramid connector and its heel area bulges to accommodate the protrusion of the glass fiber heel and base laminates. Although called a “sock,” the Spectra Sock is not similar to and does not function as a sock in the general sense. It does not come in pairs and is specifically shaped for the foot prosthesis, making it unsuitable to be worn as a regular sock. It is worn over the fiber composite foot to reduce friction and wear between the prosthetic foot and foot shell, primarily to prevent friction, reduce noise, and protect the carbon fiber and rubber shell from premature wear.

You state that the three models of Lindhe Xtend Foot prostheses, consisting of the fiber composite feet, Spectra Socks, and Foot Shells will be imported under four different scenarios:

Import Scenario 1: Complete Xtend Foot Prostheses Imported Unassembled and Packaged Together

The fiber composite foot, Spectra Sock, and Foot Shell are imported unassembled, individually packaged but bundled together. The fiber composite foot is packaged in a transparent plastic bag, and the Foot Shell and Spectra Sock — with the Spectra Sock already inserted into the Foot Shell — are packaged together in a separate plastic bag. At the time of import, the two bagged items are bundled together in an external wrapping, and each component is ready for assembly without being subject to further processing or operations. Your client will then pack the bundled components together with a care guide, warnings, warranty information, and instructions for use. After that, the Xtend Foot prostheses will be shipped to a prosthetic or orthopedic clinic or practitioner, where the prosthesis will be assembled, connected to the socket on the patient’s residual limb, and adjusted for the patient’s gait.

Import Scenario 2: The fiber composite feet are imported separately.

Import Scenario 3: The Spectra Socks and Foot Shells are imported separately

Import Scenario 4: The fiber composite feet and matching Foot Shells with inserted Spectra Socks are imported in the same shipment but in unassembled form and packaged separately. You state that your client has the capability to segregate and track each fiber composite foot and corresponding Foot Shell with inserted Spectra Sock such that only components imported in a single shipment will be packed together in a shipment to the ultimate user, and components from one shipment will not be commingled or intermingled with components from other shipments.

The applicable subheading for the three models of Lindhe Xtend Foot prostheses, the fiber composite feet, the Spectra Socks, and the Foot Shells when imported in four scenarios will all be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “artificial parts of the body …: [o]ther artificial parts of the body and parts and accessories thereof: [o]ther.” The general rate of duty will be free.

In your submission you requested consideration of a secondary classification under 9817.00.96, Harmonized Tariff Schedule of the United Sates (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 Xtend Foot Först, Xtend Foot Trenne, and Xtend Foot Fri are foot prostheses specially designed for amputees, who are considered physically disabled. As articles specially designed or adapted for physically handicapped persons, these items qualify for duty-free treatment under subheading 9817.00.96, HTSUS, when imported under the four described scenarios.

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 Forkan
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division