CLA-2-90:OT:RR:NC:N3:135
Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Ave., 24th floor
New York, NY 10022
RE: The tariff classification of headgear clips from China and Costa Rica
Dear Ms. Abraham:
In your letter dated September 18, 2025, you requested a tariff classification ruling on behalf of Philips RS
North America LLC. Additional information was provided by email October 6, October 8 and October 9,
2025.
The four types of headgear clips under consideration are integral to CPAP masks designed exclusively for
Philips DreamStation™ CPAP Sleep Therapy devices. These devices deliver continuous airway pressure
(CPAP) and Bilevel Positive Airway Pressure (BiPAP) therapy for patients with obstructive sleep apnea. The
headgear clips serve to attach the headgear to the mask frame.
Each clip type is uniquely designed for a specific Philips RS North America CPAP mask. ComfortGel
Headgear Swivel Clips are plastic rectangles with a protruding straight ball connector, used with the
ComfortGel Blue Nasal Mask. Altis Clips Set consists of plastic clips that are either round (keyring style) or
triangular with a slot, used with the Altis Full Face Mask. Wisp Headgear Clips are plastic, round-ended
rectangles, characterized by a slot on one end and a button on one side, for the Wisp Nasal Mask. PICO
Headgear Clips are plastic and trapezoidal in shape with a hook, designed for the PICO Nasal Mask.
You state that each set of clips is specifically designed to work with its specific mask design. The headgear
clips attach the headgear to the frame by a mechanical connection such as a talon hook onto a plastic
bar-shaped attachment point, a button-like press fit, or a ball fitting into a socket attachment point. You
explain that the clip features match the size, thickness and shape of each headgear and mask point of
attachment. They are specifically designed for and can only be used exclusively with Philips RS North
America CPAP Masks. They are not interchangeable with other Philips RS North America CPAP masks, nor
any competitor’s CPAP headgear and mask.
The applicable subheading for the headgear clips 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
9019.20.0000, 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 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: “Articles 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 . . . Other.” 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 clips are sold to be used solely with Philips’ BiPAP and CPAP
devices for individuals with chronic sleep apnea. The masks serve as a conduit through which the oxygen is
delivered and are integral to the successful function of the devices. They are indispensable parts for the
devices to assist sleep apnea impaired persons and specially designed for and marketed to them. Their use by
the general public is improbable. Customs and Border Protection 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 N346210 (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 clips 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
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division