The eligibility under the Nairobi Protocol of osteoarthritis knee braces from China

N350392
July 16, 2025
CLA-2-98:OT:RR:NC:N3135
CATEGORY: Classification
TARIFF NO.: 9817.00.96
Jennifer Tipping Global Trade Attorneys, LLC 2897 North Druid Hills Road NE, #185 Atlanta, GA 30329-3924 RE: The eligibility under the Nairobi Protocol of osteoarthritis knee braces from China Dear Ms. Tipping: In your letter dated June 18, 2025, you requested a tariff classification ruling on behalf of Vive Health, LLC. The products under consideration are four Coretech osteoarthritis (“OA”) knee braces: (1) 843 OA Knee Brace (SKU: SUP2027BLK); (2) 845 Dual OA Knee Brace (SKU: SUP2079BLK); (3) Offloader Elite (SKU: SUP3072BLK); and (4) Dual Offloader Elite (SKU: SUP3076). These braces are designed primarily for people with osteoarthritis (a chronic degenerative disability with no known cure) but also support chronic conditions like rheumatoid arthritis. The Coretech 843 OA Knee Brace features 12 hinge clips that allow licensed medical professionals to adjust and limit the range of motion as required and delivers targeted support through multiple leverage points, aiding in the stabilization of the knee joint. Its offloading hinge assists in redistributing pressure associated with osteoarthritis, promoting improved joint alignment. This brace is designed for long-term clinical management of chronic knee conditions under the supervision of licensed medical professionals. The Coretech 845 Dual OA Knee Brace is designed to provide medial and lateral offloading support for individuals managing chronic knee conditions such as osteoarthritis. The dual hinge system aids in redistributing pressure across the knee joint to enhance stability during extended use. Hinge flexion adjustments can be made using the included keys to suit the prescribed range of motion. The Coretech Offloader Elite is engineered to provide high-level support with strategically placed leverage points for stabilizing knees affected by chronic conditions such as osteoarthritis. Its offloading hinge is designed to assist in realigning the knee joint and redistributing pressure to enhance long term joint function. The brace enables clinicians to limit and control knee motion as prescribed.

The Coretech Dual Offloader Elite is engineered to provide comprehensive medial and lateral knee support for individuals managing chronic conditions such as osteoarthritis. By redistributing pressure across both sides of the knee joint, it enhances alignment and contributes to joint stability during extended clinical use. Hinge adjustments can be made using the included keys to set the appropriate flexion range as directed by a licensed medical professional. You state Vive Health developed its Coretech product line to serve only licensed healthcare practitioners and businesses. Coretech sells high-quality orthopedic bracing exclusively to licensed medical professionals treating patients with chronic musculoskeletal (MSK) conditions. These professionals support patients with chronic MSK conditions like degenerative disc disease, osteoarthritis, or scoliosis. Coretech items are sold only in licensed Durable Medical Equipment (DME) stores or through a medical professional. Coretech products are not sold directly to patients, but only to licensed healthcare practitioners and businesses. Online purchases are limited to licensed healthcare practitioners and businesses, who must establish an account and login to the Vive Health Business Portal. This requirement exists in part because the items must be customized by a trained fitting professional for each patient. Vive Health is the sole manufacturer and importer of the Coretech OA knee braces. The subject OA knee braces are purchased from the DME stores or through a doctor. The fit of each item is customized by trained professionals to support a specific patient, distinguishing them from items that would be useful to the general public. Use by the general public is unlikely. You claim that these OA knee braces are specially designed for individuals with a permanent or chronic physical impairment that significantly limits walking. You explain that specialized offloading hinges and adjustable pressure systems are designed to redistribute joint forces and reduce pain specifically associated with knee OA. The distinctive feature of the OA knee braces is the offloading hinge, which realigns the knee joint and reduces pressure on the damaged cartilage area. This mechanical unloading specifically targets OA pain and joint degeneration. These features are medically necessary for OA treatment but have no practical benefit for users without the condition. Other hinged braces provide general support but do not offer the targeted unloading feature needed for treating OA. You state that the Centers for Medicaid and Medicare Services (CMS) categorizes standard hinged knee braces and OA knee braces separately. The Coretech OA knee braces have been approved by the CMS for Healthcare Common Procedure Coding System (HCPCS) code(s) for billing Durable Medical Equipment Medicare Administrative Contractors. All products carry two HCPCS codes. OA braces are medically coded and require physician documentation for insurance reimbursement. Usage data shows that nearly all prescriptions of OA knee braces are for chronic impairments; transient use is rare and typically not approved for reimbursement. In your submission you requested consideration of a classification under 9817.00.96, HTSUS, which applies to articles and parts 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. Based on the information supplied, the four Coretech OA knee braces do satisfy the five factors set out by CBP. As a result, it is the opinion of this office that they are eligible for duty-free treatment 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 [email protected].
Sincerely,
(for) James Forkan Acting Director National Commodity Specialist Division