Eligibility for duty-free treatment under Nairobi Protocol concerning Airvo 3 Respiratory Support System components from New Zealand.

N357727 February 9, 2026 CLA-2-90:OT:RR:NC:N3:143 CATEGORY: Classification TARIFF NO.: 9817.00.96 Parker White Foley and Lardner LLP 777 E Wisconsin Ave Milwaukee, WI 53202-5300 RE: Eligibility for duty-free treatment under Nairobi Protocol concerning Airvo 3 Respiratory Support System components from New Zealand. Dear Mr. White: In your letter dated January 12, 2026, you requested a tariff classification ruling on behalf of your client, Fisher & Paykel Healthcare (FPH) Corporation Limited. The items in consideration are the Airvo 3 (Item No. PT301US), the Airvo Airspiral Circuit (Item No. 900PT561), the Airvo Airspiral Circuit with Neb Adaptor (Item No. 900PT563), and the Optiflow Duet Cannula (Item No. OPT964). The Airvo 3 is a respiratory support device that delivers high flows of warmed and humidified respiratory gases to infant, child, adolescent, and adult patients, including those with bypassed upper airways. The device conditions either room air or a blended mixture of air and medical oxygen by adding heat and moisture. Depending on the patient interface, the Airvo 3 can deliver flow rates from 2 to 70 liters per minute. The Airvo 3 provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to support patients with respiratory distress and/or hypoxemia in the hospital setting. These patients typically have underlying permanent or chronic respiratory conditions such as asthma, bronchiectasis, chronic obstructive pulmonary disease (COPD), chronic respiratory insufficiency, cystic fibrosis, pulmonary emphysema, respiratory failure, or a combination of these. The Airvo 3 is not intended to provide total ventilatory support for patients with acute respiratory distress. Rather, it is primarily used to support patients with chronic respiratory disease whose condition requires prescription use and clinical supervision in hospital, sub-acute, or home health care settings. The Airvo Airspiral Circuit is a heated breathing tube designed for use with FPH’s Airvo 3 Respiratory Support System to deliver warmed and humidified respiratory gases. This single-patient component connects the Airvo 3 to an Optiflow nasal cannula for the delivery of humidified respiratory gases to patients. The Airvo AirSpiral Circuit is an essential component required for proper operation of the Airvo 3 Respiratory Support System. The Airvo Airspiral Circuit with Neb Adaptor is a modified version of the Airvo Airspiral Circuit that incorporates a nebulizer adaptor. This single-patient-use device enables aerosolized albuterol sulfate delivery to adult tracheostomy patients receiving high-flow, humidified gases. It connects the Airvo 3 system to the Optiflow nasal cannula for combined humidification and aerosol therapy. The Optiflow Duet Cannula is a nasal cannula designed for use with compatible respiratory humidifiers, such as Airvo 3, to deliver high-flow, warmed, and humidified gases to spontaneously breathing adult or pediatric patients with chronic respiratory conditions. It is suitable for use in hospitals, with sub-acute and long-term care facilities, and may also be used in home care under professional guidance. In your submission you requested consideration of a classification 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. A person suffering from permanent or chronic breathing impairment is physically handicapped as that term is defined in U.S. Note 4(a) to Subchapter XVII, Chapter 98, HTSUS. The Airvo 3 Respiratory Support System is designed to support patients suffering from permanent or chronic respiratory conditions, such as asthma, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), chronic respiratory insufficiency, cystic fibrosis, pulmonary emphysema, respiratory failure, or some combination thereof, whose underlying disease state has risen to a level requiring prescription and supervision provided in a hospital, sun-clinical, or home health care setting. CBP has classified similar respiratory humidifier products as eligible for duty-free treatment under subheading 9817.00.96, HTSUS. Further, CBP has determined that component parts that are specifically designed to work exclusively with a device classifiable in subheading 9817.00.96, HTSUS, are eligible for subheading 9817.00.96, HTSUS treatment. In Headquarters Ruling Letter (“HQ”) H349574, dated August 25, 2025, CBP held that a heated breathing circuit, a water chamber, a water chamber adapter and a nasal cannula, which are used exclusively with the Bonhawa respiratory humidifiers, and designed for individuals with chronic respiratory conditions such as COPD, chronic heart failure and interstitial lung disease were eligible for subheading 9817.00.96, HTSUS treatment. Similarly, the Airvo 3, Airvo Airspiral Circuit, and the Airvo Airspiral Circuit with Neb Adaptor, are designed for and essential for the operation of the Airvo 3 Respiratory Support System. Based on the information provided and precedent ruling, Airvo 3, Airvo Airspiral Circuit, and the Airvo Airspiral Circuit with Neb Adaptor, are components specifically designed for or adapted for use in the Airvo 3 Respiratory Support System and are eligible for the subheading 9817.00.96, HTSUS. The Optiflow Duet Cannula is a component designed for use with specified respiratory gas humidifiers, such as Airvo3 Respiratory Support System, FP950 Humidifier or MR850 Respiratory Humidifier. These respiratory gas humidifiers are intended to treat spontaneously breathing adult or pediatric patients with chronic respiratory conditions in hospitals, Intensive Care Units and/or long-term care facilities. As such, the Optiflow Duet Cannula also qualifies 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 Frequently Asked Questions on the Trade Remedy/IEEPA page at https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ. 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 dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division