Eligibility for duty-free treatment under Nairobi Protocol concerning the ATMOS C 051 Thorax from Germany.

N359929 April 15, 2026 CLA-2:OT:RR:NC:N3:143 CATEGORY: Classification TARIFF NO.: 9817.00.96 David Guy ATMOS Inc 29 Dowling Forge Rd Exton, PA 19341 RE: Eligibility for duty-free treatment under Nairobi Protocol concerning the ATMOS C 051 Thorax from Germany. Dear Mr. Guy: In your letter dated March 20, 2026, you requested a tariff classification ruling. The item under consideration is the ATMOS C 051 Thorax, a digital, portable thoracic drainage system designed for use with an indwelling chest tube. It enables the continuous evacuation of pleural air and fluid in patients experiencing pneumothorax or persistent pleural air leakage. The system generates a controlled vacuum near the patient and features an electronic monitoring system that displays both the actual vacuum measured on a patient’s side, and the presence of any air leaks. The Thoracic drainage systems, such as the ATMOS C 051 Thorax, help restore lung expansion by continuously evacuating air and fluid in the pleural space, thereby maintaining the negative intrapleural pressure required for effective ventilation. This compensatory function is essential for reestablishing the mechanical conditions necessary for proper lung expansion. Pneumothorax or persistent pleural air leakage restricts lung expansion, impairs ventilation and compromises breathing. Ongoing drainage management and monitoring are especially important in patients with underlying chronic pulmonary diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung diseases, fibrosing lung diseases, cystic lung diseases, and pulmonary malignancies. It is important to note that this system is intended for situations where air and fluids in the thorax must be drained, monitored and balanced in a controlled manner and is not suitable for thoracic drainage therapy in which no negative pressure should be applied to the patient. As you noted, the ATMOS C 051 Thorax incorporates design features that distinguish it from conventional thoracic drainage systems intended for short term inpatient use. It enables safe ambulatory and take-home drainage management for prolonged pleural drainage in patients with impaired respiratory function. Additionally, it utilizes more advanced technology and is offered at much higher product cost compared to conventional drainage systems, which are typically designed for supervised inpatient management and are more economically appropriate for uncomplicated acute or transient drainage situations. The thoracic drainage systems may be used in both acute and chronic situations; however, prolonged drainage is often required for patients with pre-existing chronic respiratory impairment. These patients benefit significantly from outpatient and home drainage capabilities, as they require longer drainage durations. According to the operating instructions, the ATMOS C 051 Thorax is intended for use by physicians, healthcare professionals and laypersons who have received mandatory training by a qualified healthcare professional and can be used in a hospital/clinic environment and for home use environment. 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: “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 person 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. The ATMOS C 051 Thorax is intended for thoracic drainage to remove air or fluid from the pleural cavity in patients experiencing pneumothorax or persistent pleural air leakage. As you have noted, patients with pneumothorax or persistent pleural air leakage often suffer from underlying diseases that substantially impair respiratory function, affecting the major life activity of breathing. Based on the information provided, it is our opinion that patients suffering from pneumothorax or persistent pleural air leakage are considered physically handicapped as defined in Chapter 98, Subchapter XVII, U.S. Note 4(a). The ATMOS C 051 Thorax is specifically designed for the benefit of such persons and is therefore eligible 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 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 P. Forkan Director National Commodity Specialist Division