The eligibility under the Nairobi Protocol of an Extremit-Ease Compression Garment from China

N351227
August 4, 2025
CLA-2-98:OT:RR:NC:N3:135
CATEGORY: Classification
TARIFF NO.: 9817.00.96
George Borak Amerx Health Care Corp 164 Douglas Rd E Oldsmar, FL 34684 RE: The eligibility under the Nairobi Protocol of an Extremit-Ease Compression Garment from China Dear Mr. Borak: In your letter dated July 10, 2025, you requested a tariff classification ruling. A sample (SKU#E010142) that was submitted in a previous ruling was examined and disposed of. The Extremit-Ease Compression Garment is a circumferential gauntlet that provides 30-50 mmHg compression to help reduce mild to moderate swelling from lymphedema, chronic venous insufficiency, acute port-operative edema, and other swelling disorders. You clarify that the other swelling disorders refer to less common but still chronic medical conditions, such as lipedema, chronic kidney disease, etc., that can present in the form of edema in the lower extremities. The Extremit-Ease Compression Garment consists of a textile compression wrap featuring a zipper and four pull tabs with bungee laces, an EXTREMIT-EASE Garment Liner (a mild compression liner), and a mesh laundry bag, packaged in a retail bag for sale. The compression wrap is intended to be worn from the calf to the ankle on either leg. The Extremit-Ease Compression Garment is available in various sizes and lengths. You explain that compression garments are “graded” based upon the level of compression provided. Higher compression levels are designed more for those with chronic edema. The Extremit-Ease Compression Garment is classified as “Extra Firm” compression, or “Medical” Compression where a prescription is needed. You state that due to the complex design, the high profile of the product and the compression levels attained, this product is discernable by the average consumer as a much more robust compression garment. Non-handicapped individuals seeking compression for occasional symptoms would gravitate toward stockings or garments of lower compression and complexity. You claim that the device is used primarily for patients with chronic medical conditions verses acute post-operative conditions and is predominantly sold to physicians to dispense to their patients based on your sale tracings. You confirm that this product was specifically designed to provide 30-50mmHG of compression to assist patients suffering from chronic conditions such as lymphedema and chronic venous insufficiency.

In your submission you requested consideration of a classification under subheading 9817.00.96, HTSUS, which 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.” 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. In Sigvaris, Inc, v United States (Slip Op. 17-60, dated May 17, 2017), the Court of International Trade ruled on the classification of the graduated compression arm-sleeves and gauntlets that were designed to apply 30-40mmHg of compression to reduce swelling and force pooled lymph fluid to circulate out of the extremit y. They were predominantly worn by women who suffered from long-term upper-limb lymphedema following a mastectomy. The court held that the graduated compression arm-sleeves and gauntlets were classifiable under subheading 9817.00.96, HTSUS. In this case, the Extremit-Ease Compression Garment is used primarily by patients suffering from chronic conditions such as lymphedema and chronic venous insufficiency. It is prescribed by a doctor to help the patient reduce swelling in the leg associated with chronic conditions. It applies more pressure than the graduated compression arm-sleeves and gauntlets that the CIT found eligible under subheading 9817.00.96 in Sigvaris. Based on the information supplied, it is our opinion that the Extremit-Ease Compression Garment qualifies 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