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

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

RE: The tariff classification of a stationary oxygen concentrator from China

Dear Mr. Robeson:

In your letter dated May 12, 2025, you requested a tariff classification ruling on behalf of your client, Caire Inc.

The product under consideration is the HomeStyle Aspen 5 L Stationary Oxygen Concentrator for use in a professional healthcare facility and/or home care environment. It measures 15 x 9 x 23.3 inches and weighs 32 lbs. The electrically powered device has a top handle and four wheels on the bottom. The unit’s front housing has a digital panel with timing and counts displayed for the end user. It is intended as an oxygen supplement device (for adults only). The unit works by pulling room air through the concentrator by a small motor/compressor. The air goes through a heat exchanger and surge tank to pass through molecular sieve beads into a product tank. The oxygen is delivered to the user from the tank through a hose with help from a pressure regulator and flow meter valve. The unit provides an oxygen flow rate of 0.5 - 5 L/min with an oxygen concentration level between 95.5 percent - 87 percent and has a minimum operating time of 15 minutes. You state that the device is specifically designed for the treatment of chronic respiratory conditions (such as COPD, pulmonary fibrosis, and other chronic lung diseases and disorders) and is only available for purchase directly from Caire or one of its health care distributors with a valid medical prescription.

The applicable subheading for the stationary oxygen concentrator 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 from all countries will be subject to an additional 10 percent ad valorem rate of duty. 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.

However, the additional duties imposed by heading 9903.01.24 or 9903.01.25 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 9817.00.60, 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 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. Based on the information provided, the HomeStyle Aspen Stationary Oxygen Concentrator is specially designed for the benefit of users with chronic respiratory conditions such as COPD. Caire Inc. specifically markets and sells the device for this specific class of persons via health care distributors or its own website. A prescription is required from a doctor to purchase this device. In Headquarters Ruling Letter (HQ) H301481, dated June 14, 2019, CBP determined that a portable oxygen concentrator qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. It is the opinion of this office that patients who suffer from chronic breathing impairments and require long-term oxygen therapy are physically handicapped and the oxygen concentrator designed or adapted for the use and benefit of physically handicapped persons 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,

Steven A. Mack
Director
National Commodity Specialist Division