CLA-2-90:OT:RR:NC:N3:135

David Robeson
Mohawk Global
123 Air Cargo Road
Syracuse, NY 13212

RE: The tariff classification of a printed circuit board assembly (CB191-4) from India

Dear Mr. Robeson:

In your letter dated September 15, 2025, you requested a tariff classification ruling on behalf of your client, S ienna Corporation.

The subject CB191-4 printed circuit board assembly (Main Circuit Board/O2 Monitoring) is described as a part used exclusively for the Freestyle Comfort Oxygen Concentrator (FSC). The FSC is specifically designed for individuals with chronic respiratory conditions, disabilities, or medical conditions like Chronic Obstructive Pulmonary Disease (COPD) who require prescribed supplemental oxygen. By increasing blood oxygen saturation to over 90% SpO2, the supplemental oxygen enhances users’ quality of life and mobility.

The printed circuit board assembly is the main circuit board for the FSC and controls and contains the onboard flow sensor for the FSC. The sensor detects the purity level of the outgoing oxygen from the product ’s tank and alerts the user if it falls below 85% ± 3% purity. The printed circuit board assembly has a rectangular shape and approximate dimensions of 7.8” X 4.5”. It consists of an oxygen sensor, which is the main component, and a variety of other components, such as IC, capacitors, resistors, and transistors. The components are inserted into the board in India via Surface Mount Technology.

You state the printed circuit board assembly’s form, fit, and function are only compatible with the FSC. Without it, the FSC has no way to control the oxygen flow in the unit. The design allows this part to be used as part of the FSC and is proprietary. The printed circuit board assembly is custom to the FSC unit and has no other practical uses.

The applicable subheading for the printed circuit board assembly (CB191-4) 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 August 27, 2025, Executive Order 14339 imposed additional duties on products from India. At this time, products of India provided by heading 9903.01.84, except for products described in headings 9903.01.85 – 9903.01.89, will be subject to an additional ad valorem rate of duty of 25 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.84, 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 India will be subject to an additional ad valorem rate of duty of 25 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.02.26, in addition to subheading 9019.20.0000, HTSUS, listed above.

However, the additional duties imposed by heading 9903.01.84 or 9903.02.26 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, 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 9817.00.96, 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 United States 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 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.

In Headquarters Ruling Letter (HQ) H301481, dated June 14, 2019, CBP concluded that the specific class of persons for which Inogen’s portable oxygen concentrator was intended was physically handicapped and determined that the portable oxygen concentrator qualified for duty-free treatment under subheading 9817.00.96, HTSUS. The FreeStyle Comfort portable oxygen concentrator is designed for users with chronic breathing impairments and prescribed by doctors to the users for oxygen therapy. It is also eligible for duty-free treatment under subheading 9817.00.96, HTSUS. Based on the information provided, the printed c ircuit board assembly (CB191-4) is a part specially designed for the FreeStyle Comfort portable oxygen concentrator. As such, it qualifies 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 [email protected].
Sincerely,

(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division