N358128

N358128 February 13, 2026 CLA-2:OT:RR:NC:N143 CATEGORY: Classification TARIFF NO.: 9019.20.0000; 9817.00.96 David Robeson Consultant 123 Air Cargo Road North Syracuse, NY 13212 RE: The tariff classification of Freestyle Comfort (FSC) Oxygen Concentrator components from China. Dear Mr. Robeson: In your letter dated January 23, 2026, you requested a tariff classification ruling on behalf of CAIRE Inc. The items in consideration are FSC Compressor Inlet Tube (Part TU289-1), the FSC Purge Tubing (Part TU284-1), and the Mount Isolator (Part M0042-2). These components are used exclusively for the FSC Oxygen Concentrator. The FSC Compressor Inlet Tube (Part TU289-1) is made of medical grade silicone rubber and molded into a complex shape. The tube has a diameter of about 0.25” and covers a length of about 4 inches. The FSC Compressor Inlet Tube is designed with specific dimensions including thickness, length, and material, to channel air flow to the compressor. These dimensions and design allow the part to be used as a part of the FSC Oxygen Concentrator. The FSC Purge Tubing (Part TU284-1) is made of silicone that is flexible and translucent. The tube is a single component, comprising of a 4.2” straight section and a small angle section with a diameter of about 0.25”. The purge tube is designed to channel waste gas from two valves to the exhaust muffler. These dimensions and design allow the part to be used as a part of the FSC Oxygen Concentrator. The Mount Isolator (Part M0042-2) consists of three parts: the aluminum bracket, the black silicone and the stainless-steel bushing. The aluminum bracket provides mounting points to secure to the FSC device, the silicone dampens vibration from the compressor, and the stainless-steel bushing provides a strong mounting point or a screw to secure the compressor to the mount. The Mount Isolator is used to attach the compressor to the center structure of the FSC Oxygen Concentrator. It provides friction to prevent isolator rotation during compressor installation. This part is designed with specific form, fit, and function to be compatible only with the FSC Oxygen Concentrator. 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. The applicable subheading for the FSC Compressor Inlet Tube (Part TU289-1), the FSC Purge Tubing (Part TU284-1), and the Mount Isolator (Part M0042-2) will be 9019.20.0000, Harmonized Tariff Schedule of the United States (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 FSC Compressor Inlet Tube (Part TU289-1), the FSC Purge Tubing (Part TU284-1), and the Mount Compressor Isolator (Part M0042-2) 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. In Headquarters Ruling H301481 (dated Jun 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, eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The FSC Compressor Inlet Tube (Part TU289-1), the FSC Purge Tubing (Part TU284-1), and the Mount Isolator (Part M0042-2) are also parts of the FSC Oxygen Concentrator that are specially designed with the 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 rat

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 dionisia.y.melman@cbp.dhs.gov. 
Sincerely,
 (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division