H349574

H349574 September 25, 2025 OT:RR:CTF:VS H349574 AP CATEGORY: Classification Sen Liang Telesair, Inc. 199 Technology Dr., Suite 110 Irvine, CA 92618 RE: Bonhawa Respiratory Oxygen Platform Components; 9817.00.96, HTSUS Dear Mr. Liang: This is in response to your May 16, 2025 ruling request, submitted on behalf of Telesair, Inc. (“importer” or “Telesair”), regarding the applicability of subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), to four components (a heated breathing circuit, a water chamber, a water chamber adapter, and a nasal cannula) used exclusively with the Bonhawa Respiratory Oxygen Platform (“respiratory humidifier”), a medical device developed by the importer. FACTS: The Bonhawa Respiratory Oxygen Platform is a high-flow oxygen respiratory humidifier for the treatment of respiratory insufficiency .1 for spontaneously breathing patients with warmed and humidified respiratory gases It is intended for use by healthcare professionals in hospitals and long-term care facilities and is only sold to hospitals, long-term care facilities, and professional medical distributors. You state that while the respiratory humidifier is capable of supporting both acute and chronic respiratory conditions, the respiratory humidifier’s primary use is for long-term oxygen therapy under prescription and supervision for chronic respiratory conditions such as chronic obstructive pulmonary disease (“COPD”), idiopathic pulmonary fibrosis (“IPF”), and humidity deficits in tracheostomy patients. You further state that even when the respiratory humidifier is used acutely for respiratory failure often stemming from exacerbation of underlying chronic 1 See Bonhawa High Flow Oxygen Therapy (“HFOT”) System, https://www.telesair.com/product (last visited Aug. 22, 2025). The respiratory humidifier has an extended flow range for severe respiratory insufficiency (up to 70 liters per minute). diseases such as COPD, chronic heart failure, and interstitial lung diseases, “it is functioning as part of a long-term care continuum, not as a one-time or wellness-based solution.” The respiratory humidifier is only available by prescription and is registered as a Class II medical device with the U.S. Food and Drug Administration (“FDA”). You explain that the device is not available in general retail stores or marketed for wellness or general use, and all promotional efforts are made through medical trade shows, clinical evaluation programs, and hospital-based demonstrations. The products under consideration in this ruling are a heated breathing circuit, a water chamber, a water chamber adapter, and a nasal cannula, which are used exclusively with the Bonhawa respiratory humidifier. These four components are packaged together in a sealed plastic bag and referred to as a heated breathing circuit set. The heated breathing circuit is a single-use tube assembly. The heated breathing circuit delivers warm, humidified gas from the humidifier to the patient. It includes integrated sensors and heating elements compatible only with the Bonhawa respiratory humidifier. It consists of a single circuit tube measuring 200 cm in length with special connectors, integrated heating wires, and a temperature sensor that are electronically regulated by the Bonhawa respiratory humidifier to maintain target gas temperature and to avoid condensation. The sensor in the heated breathing circuit is located close to the patient interface and provides monitoring of the gas temperature for the device. This feature is designed for clinicians to monitor device temperature and safety. The heated breathing circuit is connected to the Bonhawa respiratory humidifier via the water chamber adapter. The water chamber is a single-use water reservoir that holds sterile water for humidification, which is molded to interface with the respiratory humidifier base. The water chamber has a medical level plastic chamber wall, 12 cm diameter aluminum base, and Di(2- ethylhexyl)phthalate (“DEHP”)-free tubing for auto water refill. During therapy, gas is passed over the water surface or through a heated plate to produce humidified air. The chamber is designed to fit precisely into the Bonhawa respiratory humidifier’s housing and heater plate. The water chamber adapter connects the disposable water chamber, the main device, and the breathing circuit. It ensures airtight operation and enables the system to heat and humidify the gas stream. The adapter contains connection ports for both gas and electrical flow monitoring and is designed to be replaced with each new water chamber and breathing circuit. The nasal cannula is the patient interface for gas delivery and delivers humidified oxygen or air to the nostrils. The nasal cannula has a 2.2 cm standard swivel connector with a neck strap, gas delivery conduit, head strap, nasal prong interface, and retaining clip. It connects to the end of the breathing circuit and is designed for comfortable extended wear. The cannula is optimized for high flow therapy, with reinforced prongs and tubing designed to handle the temperature and humidified air set by the Bonhawa respiratory humidifier. 2 ISSUE: Whether the heated breathing circuit, water chamber, water chamber adapter, and nasal cannula, which are used exclusively with the Bonhawa respiratory humidifier, are eligible for subheading 9817.00.96, HTSUS, treatment, and whether any additional tariffs will apply. LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty- free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” Thus, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). 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. You explain that while the respiratory humidifier is capable of supporting both acute and chronic respiratory conditions, the respiratory humidifier’s primary use is for long-term oxygen therapy under prescription and supervision for chronic respiratory conditions such as COPD, IPF, and humidity deficits in tracheostomy patients. You further state that even when the respiratory humidifier is used acutely for respiratory failure often stemming fr

The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty- free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” Thus, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). 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 article