CLA-2-90:OT:RR:NC:N3:135
Daniel Labi
HLS
4348 NW 120th Ave.
Coral Springs, FL 33065
RE: The tariff classification of an oxygen concentrator from China
Dear Mr. Labi:
In your letter dated August 19, 2025, you requested a tariff classification ruling.
Spirit - 8050 is a 5 L stationary oxygen concentrator designed to provide continuous oxygen therapy for
patients who are experiencing low oxygen levels due to various respiratory conditions such as chronic
obstructive pulmonary disease (COPD) and other disorders requiring long-term oxygen supplementation. It
measures 14.96 × 8.97 x 23.3 inches (L x W x H) and weighs 31.96 lbs. The oxygen concentrator consists of
a plastic housing with a top handle, a compressor, sieve beds, a flow meter, four wheels and other parts.
Using air as raw material, the molecular sieve pressure swing adsorption process is used to produce oxygen
with an oxygen concentration range of 90% - 96% (V/V) (referred to as 93% oxygen). This device is used
under the guidance of a physician and features adjustable oxygen flow rates and alarms for any issues with
the device.
The applicable subheading for the Spirit - 8050 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 of China, Hong
Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. 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 9817.00.96, 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. Based on the information provided, the Spirit - 8050 is specially designed for the use
and benefit of users with chronic respiratory conditions such as COPD. It is the opinion of this office it is also
eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
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
Acting Director
National Commodity Specialist Division