The tariff classification and eligibility for duty-free treatment under Nairobi Protocol concerning the Mobility+ Enteral Feeding Pump System from Ireland

N362100
June 29, 2026
CLA-2-90:OT:RR:NC:N3:143
CATEGORY: Classification
TARIFF NO.: 9018.90.8000; 9817.00.96
Thomas Glynn Rockfield Medical Devices Incorporated c/o mHUB Chicago, 1623 W Fulton Street Chicago, IL 60612 RE: The tariff classification and eligibility for duty-free treatment under Nairobi Protocol concerning the Mobility+ Enteral Feeding Pump System from Ireland Dear Mr. Glynn: In your letter dated June 5, 2026, you requested a tariff classification ruling. Additional information was provided via email. The Mobility+ Enteral Feeding Pump System is a portable, lightweight, non-electronic, disposable, and mechanical device designed for individuals who require long-term enteral (tube) feeding. It enables those unable to sustain adequate oral nutrition to receive continuous or intermittent enteral nutrition in a mobile, discreet, and convenient manner. The system consists of a food pouch that acts as both the reservoir and pump, a filling set that connects commercially available nutrition formula to the pouch using ENFit (Enteral Medical Standard connection) connectors and a syringe (not included), and a giving set that connects the pouch to the patient’s implanted feeding tube. Using proprietary mechanical action that is neither electronic nor gravity-dependent, the system delivers enteral formula at a controlled rate through the giving set to nasogastric, gastrostomy, or jejunostomy tubes. It is intended for use with standard, previously implanted feeding tubes with ENFit connectors, placed in the stomach or small intestine. As noted, the Mobility+ Enteral Feeding Pump System is specifically indicated for patients who require enteral nutrition support due to chronic and permanent conditions that significantly impair their ability to eat or swallow. These conditions include, but are not limited to, neurological disorders such as Parkinson’s disease or ALS, head and neck cancers and their sequelae, gastrointestinal dysmotility disorders, Crohn’s disease and other chronic inflammatory bowel conditions, congenital disorders, and severe dysphagia. As referenced in your email dated 6/26/2026, the Mobility+ Enteral Feeding Pump System is available by prescription or as an over-the-counter (OTC) version for individuals diagnosed with feeding impairments. Both versions are physically identical but have different labeling requirements. The system is distributed exclusively through home infusion providers, enteral feeding suppliers, healthcare providers, and specialty

medical supply stores (OTC version), not through consumer retail channels. It is intended for use in both clinical and home care settings. The applicable subheading for the Mobility+ Enteral Feeding Pump System will be 9018.90.8000, Harmonized Tariff Schedule of the United Sates (HTSUS), which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: other instruments and appliances and parts and accessories thereof: other: other.” In your submission you also 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 Mobility+ Enteral Feeding Pump System is designed for patients who cannot adequately feed themselves orally, delivering nutrition formulas through a surgically or endoscopically placed tube directly into the stomach or small intestine of a patient. As indicated, individuals without chronic or permanent swallowing or nutritional impairment would have no use for this system. In ruling NY N351166 (dated July 30, 2025), CBP determined that enteral feeding tubes used primarily for individuals with long-term or permanent impairments that substantially limit their ability to eat—such as those with neurological disorders, prolonged gastrointestinal dysfunctions, and congenital or genetic disorders—qualify for duty-free treatment under

subheading 9817.00.96. Based on the information provided and this precedent, it is our opinion that patients whose underlying conditions prevent them from normal eating or nourishing themselves are considered physically handicapped as defined in Chapter 98, Subchapter XVII, U.S. Note 4(a). The Mobility+ Enteral Feeding Pump System is specifically designed for the benefit of such individuals 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 [email protected].
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division