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 stationary oxygen concentrator from China
Dear Mr. Robeson:
In your letter dated March 10, 2025, you requested a tariff classification ruling on behalf of your client, Caire
Inc.
The product under consideration is the IntenOxy 5 Stationary Oxygen Concentrator for hospital or home use.
It has a top handle, a plastic housing, and four wheels on the bottom. The top of the device has three control
buttons and an oxygen outlet. The front of the plastic housing features a display panel, a flowmeter, and a
flowmeter knob. The oxygen concentrator measures 15.35 inches x 9.65 inches x 19.69 inches (W x D x H)
and weighs 34.2 lbs. The product is intended as an oxygen supplement device (for adults only) in a
professional healthcare facility and/or a home healthcare environment. It provides a high concentration of
oxygen to persons requiring oxygen therapy by pulling in and compressing the ambient air, then separating
nitrogen from the air to provide purified oxygen for breathing to the end user. The oxygen concentration
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). It is only available with a doctor’s prescription and the item is distributed
directly by Caire Inc. or by health care distributors that have authority to provide prescription-based products.
The applicable subheading for the IntenOxy 5 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 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.
However, the additional duties imposed by heading 9903.01.24 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. For subheadings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the
value of repairs, alterations, or processing performed (in China and Hong Kong), as described in the
applicable subheading. For heading 9802.00.80, the additional duties apply to the value of the article
assembled abroad (in China and Hong Kong), less the cost or value of such products of the United States, as
described. Products of China and Hong Kong that are provided for in heading 9903.01.24 shall continue to be
subject to antidumping, countervailing, or other duties, taxes, fees, exactions and charges that apply to such
products, as well as to the additional ad valorem rate of duty imposed by heading 9903.01.24. See U.S. Note
2 (u) to Subchapter III, Chapter 99, HTSUS.
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 IntenOxy 5 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.
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