The tariff classification of bilevel positive airway pressure devices from China or other country

N353194 September 30, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9019.20.0000; 9817.00.60 Jessica Rifkin Olsson Frank Weeda Terman Matz P.C. 2000 Pennsylvania Ave. NW, Suite 4003 Washington, DC 20006 RE: The tariff classification of bilevel positive airway pressure devices from China or other country Dear Ms. Rifkin: In your letter dated September 3, 2025 , you requested a tariff classification ruling on behalf of your client, Movair Inc. Additional information was provided by email dated September 26 and September 29, 2025. The products under consideration are four models of Hypnus Bilevel Positive Airway Pressure (BPAP or BiPAP) devices: models BA825, BA825W, ST830, and ST830W. All models are intended to provide non-invasive, positive airway pressure to spontaneously breathing patients in a professional healthcare facility and/or a home healthcare environment. A doctor’s prescription is required to purchase these devices. Each device consists of a main unit, a humidifier, a heating tube, a mask, and a power supply adapter. The main unit has an interface screen indicating adjustments of ramp-time, temperature, humidity, and user settings. On the front of the device is the 22mm airway tube connection; the other side of the airway tube connects with the mask. The humidifier is filled with water via a cover on top of the device and attaches to the main unit. Based on the preset settings, the device outputs a certain level of positive airway pressure and air flow through the tubing and nasal mask to provide non-invasive ventilatory support for patients with obstructive sleep apnea or respiratory insufficiency. The inspiration duration settings of all models are Ti Min: 0.1-4.0 seconds and Ti Max: 0.3-4.0 seconds. The model BA825 and model BA825W operate within a pressure range of 4-25cmH2O and support CPAP mode, BPAP-S, and Auto BPAP-S modes. The model ST830 and model ST830W offer CPAP mode, BPAP-S, BPAP-ST, and BPAP-T modes. Both operate within a higher pressure range of 4-30cmH2O and include a respiratory rate setting of 5-40 bpm in BPAP-ST mode. The ST830W model adds wireless connectivity for data transfer, which the ST830 lacks. You explain that the construction and design of the Hypnus BiPAP devices shows that they are intended for use only by chronic patients (patients with chronic conditions). The Hypnus BiPAP machines are designed and intended for home use. BiPAP machines for home use such as the Hypnus models are intended to provide long-term management of chronic respiratory conditions such as Chronic Obstructive Pulmonary Disease (“COPD”) or sleep apnea. They are not designed for use in acute care settings, and so therefore do not have alarms and monitoring systems to continuously monitor the vital signs of the patients and allow immediate intervention to provide additional care if necessary. Instead, because they are meant for long-term use, they have features such as heated humidifiers meant to increase the comfort of their users, and are more compact and quieter than BiPAP machines meant for acute care settings. By contrast, BiPAP machines for use by patients with acute difficulty breathing (acute patients) are designed for use in an acute care setting. Because acute patients require clinical monitoring and may need immediate, emergency intervention, BiPAP machines designed and intended to treat acute patients have the following features: (1) monitoring and alarm systems, to immediately notify clinicians of any changes in patient status and allow them to make immediate changes in pressure settings and ventilation modes if necessary; (2) integration with supplemental oxygen sources, to support more critical patients; (3) the ability to deliver higher inspiratory and expiratory pressures than those that can be delivered by BiPAP machines designed for home use; (4) the ability to support more modes than those supported by BiPAP machines for home use; (5) the ability to more precisely control ventilatory parameters; and (6) a battery backup system, to ensure uninterrupted breathing support in the event of a power failure and failure of an acute care facility’s backup generator. You have attached a spreadsheet summarizing key differences between the Hypnus BiPAP machines and BiPAP machines for acute care (hospital use). As per this summary, the Hypnus BiPAP machines lack all of the key features of BiPAP machines designed for hospital use, i.e. they: (1) do not have an alarm system; (2) do not have a battery backup system; (3) do not have features supporting integration with supplemental oxygen sources; and (4) do not support patient monitoring. By contrast, the Hypnus machines have comfort features associated with long-term, home-based use by the chronically ill, i.e., they have: (1) a pressure ramp up feature; (2) expiratory pressure relief; and (3) a heating tube and a humidifier meant to provide moist, heated air. Finally, while the Hypnus manual states that these machines are “intended for hospital and home use,” the reference to hospital use was included for the sake of completeness only and does not reflect the commercial reality that the Hypnus machines are unlikely to actually be used in an acute care setting, given their lack of the significant features required for use in acute care settings as outlined above. Indeed, Movair focuses on home healthcare products, and has not previously supplied products used in acute care. Rather, Movair supplies products to home healthcare HME (Home Medical Equipment) and DME (Durable Medical Equipment) providers. You further explain that the Auto BPAP-S, BPAP-S, and BPAP-ST modes are specifically designed for the treatment of chronic respiratory conditions. All models of the Hypnus machines at issue are specially designed to provide non-invasive ventilatory support for patients with the chronic respiratory conditions of Obstructive Sleep Apnea (“OSA”) or respiratory insufficiency (in particular, Chronic Obstructive Pulmonary disease (“COPD”) and Chronic Respiratory Failure (CRF) subsequent to COPD. The BPAP-S and Auto BPAP-S modes are specifically designed to treat chronic respiratory conditions by providing respiratory assistance via two treatment pressures – one for inspiration (IPAP) and one for expiration (EPAP). The devices sense when the patient is inhaling and exhaling and supply the appropriate treatment pressures accordingly. These modes are used for patients with CRF subsequent to COPD. The Auto BPAP-S automatically adjusts treatment pressure in response to flow limitation, snore and apneas. The BPAP-ST mode provides respiratory support by augmenting any breath initiated by the patient, but will also supply additional breaths should the patient breath rate fall below the clinician’s set “Backup” breath rate. This mode is used for patients with CRF subsequent to COPD. The BPAP-T mode supplies a fixed breath rate and clinician-determined inspiration/expiration times, regardless of patient effort. This mode can be used to treat both OSA and respiratory insufficiency. The applicable subheading for the Hypnus BiPAP devices 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. Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings 9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition to subheading 9019.20.0000, HTSUS, listed above. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China, Hong Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9019.20.0000, HTSUS, listed above. If the Hypnus BiPAP devices are products of another country, they will also be subject to an additional ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, in addition to subheading 9019.20.0000, HTSUS, listed above. However, the additional duties imposed by heading 9903.01.24, 9903.01.25, or other applicable chapter 99 heading under which the reciprocal tariff applies shall not apply to goods for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and 9802.00.60. In your submission you requested consideration of a secondary 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: “[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 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. These Hypnus BiPAP devices are specifically designed for the use or benefit of persons with chronic respiratory conditions such as obstructive sleep apnea and respiratory insufficiency (e.g., COPD), which limit one or more major life activities, including breathing. The devices are not sold in general retail stores or marketed for wellness or general use. Instead, they require a doctor’s prescription and will be distributed directly by Movair Inc. to home healthcare HME (home medical equipment) and DME (durable medical equipment) providers. You state that Movair is recognized as a seller of home medical devices used to treat chronic conditions. 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. NY ruling N320095, dated July 12, 2021, stated the BiPAP devices “specifically designed” for individuals with profound chronic breathing issues were similar to Continuous Positive Airway Pressure (CPAP) respiratory devices, which qualify for duty-free treatment under subheading 9817.00.96, HTSUS. Based on the information supplied, we find that the four models of Hypnus Bilevel Positive Airway Pressure devices qualify for duty-free treatment under subheading 9817.00.96, HTSUS. The tariffs and additional 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/. 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 Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division