Eligibility for duty-free treatment under Nairobi Protocol concerning F&P 950 Respiratory Humidifier System component parts from New Zealand.

N359604 April 2, 2026 CLA-2:OT:RR:NC:N3:143 CATEGORY: Classification TARIFF NO.: 9817.00.96 Parker White Foley and Lardner LLP 777 E Wisconsin Ave, Ste 3800 Milwaukee, WI 53202-5300 RE: Eligibility for duty-free treatment under Nairobi Protocol concerning F&P 950 Respiratory Humidifier System component parts from New Zealand. Dear Mr. White: In your letter dated March 10, 2026, you requested a classification tariff ruling on behalf of Fisher & Paykel Healthcare Corporation Limited. The items under consideration are the F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045), and the F&P 950 Sensor Cartridge (Item No. 950S02). These component parts form the F&P 950 Respiratory Humidifier System and are designed to work together in the treatment of patients with primarily permanent and chronic respiratory conditions. They are intended for use in hospitals, sub-acute facilities, and long-term care facilities, under the supervision of qualified healthcare professionals. The F&P 950 Respiratory Humidifier (Item No. 950JUS) is a respiratory device designed primarily for patients with airway challenges resulting from chronic respiratory conditions such as asthma, cystic fibrosis, COPD, interstitial lung disease, bronchiectasis, bronchopulmonary, dysplasia and chronic lung disease. The device delivers heated and humidified medical gases with simultaneous oxygen delivery. It is intended for use in patients whose conditions require prescription and supervision in a hospital setting. The F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J) includes a dryline, humidification chamber, inspiratory limb, and a disposable exhalation port. Together, these components form a single limb circuit with an intentional leak for the delivery of non-invasive ventilation therapy. The kit facilitates the delivery of humidified respiratory gases generated by the F&P 950 Respiratory Humidifier to the selected Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) interface for administration to the patient. It is specifically designed as a required component part for the F&P 950 Respiratory Humidifier System. The F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045) is a single use mask intended for delivery of non-invasive positive pressure ventilation therapy to spontaneously breathing patients with respiratory failure or insufficiency. When used as part of the F&P 950 Respiratory Humidifier, the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit, and the F&P Nivairo™ Vented Hospital Full Face Mask work together to support patients with respiratory failure or insufficiency. Like the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit, the F&P Nivairo™ Vented Hospital Full Face Mask is specifically designed as a necessary component part for the F&P 950 Respiratory Humidifier System. The F&P 950 Sensor Cartridge (Item No. 950S02) contains incoming and outgoing gas temperature probes and a flow sensor. It measures the gas temperature and flow rate for humidified gases generated by the F&P 950 Respiratory Humidifier. These sensors allow caregivers to measure and control the respiratory gases delivered to patients suffering from permanent or chronic respiratory diseases. Like the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit and the F&P Nivairo™ Vented Hospital Full Face Mask, the F&P 950 Sensor Cartridge is specifically designed as a necessary component part for the F&P 950 Respiratory Humidifier System. In your submission you requested consideration of a classification 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: “[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 9817.00.60, 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 United States 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 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 F&P 950 Respiratory Humidifier System is designed to support patients suffering from primarily permanent or chronic respiratory conditions. 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, 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. As such, the F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045) and the F&P 950 Sensor Cartridge (Item No. 950S02) are designed for and essential for the operation of the F&P 950 Respiratory Humidifier System. Based on the information provided and precedent ruling, F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045) and the F&P 950 Sensor Cartridge (Item No. 950S02), are component parts specifically designed for or adapted for use in the F&P 950 Respiratory Humidifier System and are eligible for the subheading 9817.00.96, HTSUS. Lastly, the F&P 950 Adult/Pediatric Ventilator Circuit Kit (Item No. 950A81J) will be addressed in a separate correspondence. 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 dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James Forkan Designated Official Performing the Duties of the Division Director National Commodity Specialist Division