CLA-2-90:OT:RR:NC:N3:135
Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Avenue, Suite 2405
New York, NY 10022
RE: The classification of headgear and frames used with CPAP devices from China and Costa Rica
Dear Ms. Abraham:
In your letter dated August 11, 2025, you requested a tariff classification ruling written on behalf of Philips
RS North America LLC. Additional information was provided by email dated August 21, August 22, August
29, and September 3, 2025.
The products under consideration are specialized headgear and frames for use with Philips CPAP devices
under brand names Amara, DreamWear, Nuance, Wisp, and Performax. The headgear is the fabric portion of
the mask that is placed around the head and keeps the mask on the face and head. The frame is the part of the
mask that sits mainly on the face to help stabilize the mask cushion in proper place. The different brands of
headgear and frames have minor variations in size, color, etc. but offer identical functionality and
performance. They are parts of CPAP masks that are designed exclusively for the Philips DreamStation®
CPAP Sleep Therapy devices that provide continuous airway pressure (CPAP) and Bilevel Positive Airway
Pressure (BiPAP) therapy to treat patients with obstructive sleep apnea.
The applicable subheading for the specialized headgear and frames 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.
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 Costa Rica will
be subject to an additional ad valorem rate of duty of 15 percent. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, i.e. 9903.02.14, in addition to subheading 9
019.20.0000, HTSUS, listed above.
However, the additional duties imposed by headings 9903.01.24, 9903.01.25, and 9903.02.14 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 U.S. 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 U.S. Customs and Border Protection
(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 your letter, you state that the headgear and frames here are “specifically designed” as parts of sleep apnea
devices for individuals with profound chronic breathing issues like sleep apnea. They are produced to
function only with the devices and are not for use by the general public. The headgear and frames are sold to
be used solely with Philips’ CPAP and BiPAP devices for sleep apnea-impaired persons and cannot be used
with other devices. CBP has determined that the CPAP devices designed for the treatment of obstructive
sleep apnea qualify for duty-free treatment under subheading 9817.00.96, HTSUS. See NY ruling N059778
(dated May 29, 2009). Online research found that BiPAP devices are used to treat sleep apnea, particularly
when CPAP therapy is not sufficient or well-tolerated. CPAP machines deliver the same pressure when
breathing in and breathing out. BiPAP machines provide two different pressure levels, one level of air
pressure during inhalation and a lower level for exhalation. In NY ruling N34621 (dated March 26, 2025), the
face masks are used solely individuals with chronic sleep apnea and are specifically designed for use with
BiPAP and CPAP therapy devices. CBP determined that they qualified for duty-free treatment under
subheading 9817.00.96, HTSUS. Based on the information provided and the precedent, it is our opinion that
the headgear and frames are parts of the masks used solely with Philips’ CPAP and BiPAP devices for sleep
apnea-impaired persons and thus are eligible 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
Acting Director
National Commodity Specialist Division