N352352

N352352 September 10, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9021.39.0000; 9817.00.96 Michelle Lee Wright Hugh Steeper Limited Unit 3, Stourton Link Leeds LS101DF United Kingdom RE: The tariff classification of a prosthetic hand set and prosthetic elbows sets from United Kingdom Dear Mrs. Wright: In your letter dated August 13, 2025, you requested a tariff classification ruling of prosthetic elbow sets in four variants and a prosthetic hand set. Espire Elbow is an L-shaped prosthetic elbow with forearm and comes in four variants: Pro, Hybrid, Classic, and Classic Plus. These devices are Class 1 Medical Devices and are only to be purchased, configured, and fitted by a qualified prosthetist and are to be used exclusively for external prosthetic fittings of the upper limbs. They are designed to mimic anatomical shape while being intuitive and easy to use for the amputees who have suffered the loss of one arm. The Espire Elbow Pro and Hybrid processes the end-user’s input signals to activate and control powered elbow movement. The Espire Elbow Pro uses electrical signals from muscles to proportionally control a powered elbow and terminal devices, whereas the Espire Elbow Hybrid uses electrical signals from muscles to control terminal devices only. The Espire Elbow Pro and Hybrid Sets each include an Espire Elbow (either Pro or Hybrid), a lamination collar kit (clamp ring, lamination dummy, and lamination collar), a strain relief disc, two lithium-ion batteries, a battery charger with an adapter, two hex Allen keys, a power cable, a battery door, and instruction manuals. The Espire Elbow Classic and Classic Plus are mechanical. Both have a mechanical elbow with manual lock and forearm counterbalance for lift compensation and body-powered elbow operation. The Espire Elbow Classic Plus also includes provisions for myoelectric control of terminal devices. The Espire Elbow Classic and Classic Plus Sets each include an Espire Elbow (either Classic or Classic Plus), a hex Allen key, a lamination collar kit (clamp ring, lamination dummy, and lamination collar), a mounting collar, a drill bit, and instruction manuals. Myo Kinisi is a myoelectric prosthetic hand designed for amputees who have suffered the loss of a hand due to disease or through an accident. It is externally controlled by the electric signals naturally generated by the user’s muscles and powered using a high-capacity battery system housed within the forearm. It is suitable for patients at levels equivalent to transradial and more proximally, in both unilateral and bilateral applications. The hand is available in three sizes (71/4”, 73/4”, and 81/4”) and four wrist variations, to suit a broad range of clinical presentations. The Myo Kinisi must only be prescribed and fitted by a qualified prosthetist in a suitable clinical environment. The prosthetic hand kit includes a Myo Kinisi, a PVC hand shell, a technical manual, and a user guide. The applicable subheading for the Espire Elbow Pro, Hybrid, Classic, Classic Plus, and prosthetic hand sets will 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. 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 United Kingdom will be subject to an additional ad valorem rate of duty of 10 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.02.66, in addition to subheading 9021.39.0000, HTSUS, listed above. However, the additional duties imposed by subheading 9903.02.66 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: (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 Espire Elbow Pro, Espire Elbow Hybrid, Espire Elbow Classic, Espire Elbow Classic Plus, and prosthetic hand sets are prosthetic devices designed for amputees who have suffered the loss of arms or hands through accident or disease. They are articles specially designed or adapted for the use or benefit of the physically handicapped persons and qualify for duty-free treatment in su

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 Acting Director National Commodity Specialist Division