The tariff classification of Freestyle Comfort (FSC) Oxygen Concentrator component parts from China

N363181
July 28, 2026
CLA-2-90:OT:RR:NC:N3: 143
CATEGORY: Classification
TARIFF NO.: 9019.20.0000; 9817.00.96
David Robeson Mohawk Global Trade Advisors 123 Air Cargo Road Syracuse, NY 13212 RE: The tariff classification of Freestyle Comfort (FSC) Oxygen Concentrator component parts from China Dear Mr. Robeson: In your letter dated July 10, 2026, you requested a tariff classification ruling on behalf of Caire Inc. The items under consideration are the Barb Couple Silicone (Part TU288-1) and the Tubing Compressor Outlet (Part TU285-2). These component parts are exclusively designed for the FSC Oxygen Concentrator. They connect the feed/waste valves to move ambient air through the sieve beds, delivering oxygen to the user, and cannot be used in any other product. The Barb Coupler Silicone (Part TU288-1) is a custom injection-molded connector made from medical grade silicone rubber. It features raised and angled barbs on its exterior, which are designed to slide easily into tubing while resisting pull-out. The component is very small, measuring 0.9 inches in length with an outside diameter of 0.27 inches. The Tubing Compressor Outlet (Part TU285-2) is a molded, stiff, transparent tube made of polycarbonate and includes a stainless-steel bearing. The item is manufactured by injection molding the plastic piece, followed by the insertion of the stainless-steel ball into the open channels. It has two mounting points and fits into a horseshoe-shaped fitting. The main body has a total length of 3.4 inches and a width of 1.7 inches (measured from screw hole to screw hole). The secondary tubing extends slightly over 1.9 inches from the main body. The FSC Oxygen Concentrator is specifically designed for individuals experiencing breathing difficulties due to chronic diseases, disabilities or other medical conditions. The device is intended to supply supplemental oxygen that improves the patient’s quality of life and mobility by increasing their blood oxygen saturation above 90% SpO2. The FSC Oxygen Concentrator is extremely lightweight and features an ergonomic design that rests naturally against the curves of your body, making it comfortable to wear while out and about. The device features a simple, one touch operation with a color user interface, a long-lasting battery and utilizes advanced breath detection technology, such as Ultra Sense, to ensure oxygen is delivered precisely when the

user requires. FSC Oxygen Concentrators are generally prescribed only by a licensed healthcare provider to ensure proper dosage and patient safety. You suggest classification for both the Barb Coupler Silicone (Part TU288-1) and the Tubing Compressor Outlet (Part TU285-2) in subheading 3917.29.0050, Harmonized Tariff Schedule of the United States (HTSUS). We disagree. Documentation indicates that these items are specialized fittings designed for Freestyle Comfort proprietary to Caire Inc., that cannot be used interchangeably with other machines of this type. Review of photos confirms these statements. Therefore, these items are precluded from classification in 3917, HTSUS. The applicable subheading for the Barb Coupler Silicone (Part TU288-1) and the Tubing Compressor Outlet (Part TU285-2) will be 9019.20.0000, HTSUS, which provides for “[o]zone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The general rate of duty will be free. In your submission you also requested consideration of a secondary classification for the Barb Coupler Silicone (Part TU288-1) and the Tubing Compressor Outlet (Part TU285-2) 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: “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.

In Headquarters Ruling H301481 (dated June 14, 2019), CBP determined that a portable oxygen concentrator qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. Additionally, in NY ruling N349750, dated June 30, 2025, CBP determined that the Freestyle Comfort portable oxygen concentrator designed for users with chronic breathing impairments and prescribed by doctors to the users for oxygen therapy, and parts that are specifically designed as parts of the oxygen concentrators, are eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The Barb Coupler Silicone (Part TU288-1) and the Tubing Compressor Outlet (Part TU285-2) are also component parts of the FSC Oxygen Concentrator that are specially designed with specific form, fit and function, and as such qualify for duty-free treatment under subheading 9817.00.96, HTSUS. 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 Dionisia Melman at [email protected].
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division