CLA-2-84:OT:RR:NC:N1:102

Bart Van Belle
Maxon Group
125 Dever Drive
Taunton, MA 02780

RE: The tariff classification of a pump mechanism from Switzerland

Dear Mr. Van Belle:

In your letter dated October 10, 2025, you requested a tariff classification ruling. Descriptive information was submitted for review.

The product under consideration is referred to as a pump mechanism, part number 742140. The mechanism is configured as a positive displacement pump that is comprised of a body that encases a piston, a diaphragm, springs, a spindle, an inlet and additional components. Once imported, the pump mechanism is installed into the housing of a Portal Pump. The Portal Pump is an automated insulin delivery system that connects to a mobile controller application and a glucose monitor via Bluetooth Low Energy technology to manage Type 1 diabetes.

In your ruling request, you suggest classifying the pump mechanism as a part of an implantable appliance to compensate for a defect or disability under subheading 9021.90.8000, Harmonized Tariff Schedule of the United States (HTSUS) (please note that subheading 9021.90.8000 has been superseded by 9021.90.8100 in the current HTSUS). We disagree with the suggested classification. Chapter 90 Note 2 (a) states that parts and accessories which are goods included in any of the headings of this chapter or of chapter 84, 85 or 91 (other than heading 8487, 8548 or 9033), are in all cases to be classified in their respective headings.” Heading 8413 specifically provides for pumps for liquids.

This office does recognize that New York Ruling H84993, dated August 23, 2001, classified a pump mechanism within heading 9021. However, the pump mechanism in that ruling is ready to support or replace the chemical function of certain organs. As entered, the subject mechanism is simply a pump for liquids, and it is not until it is installed and connected to the internal components of the Portal Pump that insulin can be delivered to manage Type 1 diabetes. The pump mechanism is distinguishable from the appliance discussed in ruling H84993. Accordingly, the pump mechanism is excluded from Heading 9021, HTSUS. The applicable subheading for the pump will be 8413.50.0050, HTSUS, which provides for Pumps for liquids, whether or not fitted with a measuring device; liquid elevators; part thereof: Other reciprocating positive displacement pumps: Diaphragm pumps. The general rate of duty will be Free.

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 Switzerland will be subject to an additional ad valorem rate of duty of 39 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e., 9903.02.58, in addition to subheading 8413.50.0050, HTSUS, listed above.

In your submission, you also request consideration of a secondary classification for the pump mechanism under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as including “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 oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.”

The primary issue is whether the articles are specially designed or adapted for the use or benefit of the handicapped within the meaning of the Nairobi Protocol. Although the legislative history of the Nairobi Protocol discusses the concerns of Congress that the design, modification, or adaptation of an article must be significant so as to clearly render the article for use by handicapped individuals, no specific definition of these terms was established by Congress. Since it is difficult to establish a clear definition of what is specially designed or adapted, various factors must be utilized on a case-by-case basis to determine whether a given article is specially designed or adapted within the meaning of this statute.

In Treasury Directive 92-77, dated August 3, 1992 (Volume 26 Customs Bulletin Issue 35, dated August 26, 1992), U.S. Customs and Border Protection (CBP) set forth its position regarding certain issues arising under the Nairobi Protocol. The first issue concerned the interpretation of the term specially designed or adapted. CBP pointed out that a primary factor to be considered in determining whether an article was specially designed and adapted was whether the article was easily distinguishable, by properties of the design and the corresponding use specific to this unique design, from articles useful to non-handicapped individuals. Therefore, if an article is solely dedicated for use by the handicapped it is CBP’s position that this would be conclusive evidence that the article is specially designed or adapted for the handicapped for purposes of the Nairobi Protocol.

In Headquarters Ruling Letter 556449, dated May 5, 1992, CBP set forth five factors it would consider in determining whether an article is specially designed or adapted for the use or benefit of handicapped persons. These factors include: (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.

Based on the information supplied, the subject pump mechanism does not satisfy the five factors set out by CBP. While the pump is manufactured to feature a certain stroke volume in use, it does not possess any other features that make it easily distinguishable from articles useful to non-handicapped persons when considering the properties of its design, form and corresponding use. The characteristics of the pump do not create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public. Furthermore, the product will not be imported by a distributor recognized or proven to be involved in this class or kind of articles for the handicapped. Accordingly, the pump mechanism is not eligible for HTSUS provision 9817.00.96.

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 Sandra Martinez at [email protected].
Sincerely,

(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division