CLA-2-90:OT:RR:NC:N3:135
Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Avenue, 24th floor
New York, NY 10022
RE: The tariff classification of Optilife chin straps from Mexico, Costa Rico, and Dominican Republic
Dear Ms. Abraham:
In your letter dated September 16, 2025, you requested a tariff classification ruling on behalf of Philips RS
North America LLC. Additional information was provided by email dated October 3, October 6, and October
8, 2025.
The items under consideration are three types of Optilife chin straps - Chin Strap, Deluxe Chin Strap and
Premium Chin Strap) - for CPAP nasal and nasal pillow masks that are designed exclusively for the Philips
DreamStation™ CPAP Sleep Therapy devices. These devices provide continuous airway pressure (CPAP)
and Bilevel Positive Airway Pressure (BiPAP) therapy to treat patients with obstructive sleep apnea. The chin
straps are made of fabric with Velcro attachment points for sizing and adjustments. Their purpose is to keep
the user’s mouth closed during therapy, ensuring the proper delivery of continuous positive airway pressure.
Users select a chin strap based on size and personal preference.
The Optilife Chin Strap cradles the chin and extends diagonally past the ear to the back of the head, secured
with a hook and loop closure. The Optilife Deluxe Chin Strap is a basic closed loop, approximately 4 inches
wide, extending from the chin to the top of the head fastened by a hook-and-loop closure. It also has an
anchoring strap for stability. The Optilife Premium Chin Strap cradles the chin and extends vertically to the
top of the head, with a sewn-in strap that tightens around the back of the head. These chin straps provide a
non-intrusive method of gently keeping the mouth closed, enabling the CPAP Sleep Therapy device to
function effectively. They are worn over nasal masks or nasal pillow masks and feature minimal contact
points on the top or back of the head to ensure compatibility with the masks. This design allows the device to
deliver therapy according to the prescription, particularly for users who cannot tolerate a full-face mask.
Chin straps are required for nighttime mouth breathers, as therapy becomes ineffective if the mouth opens
during sleep. Properly positioned chin straps ensure the delivery of continuous positive airway pressure,
prevent bacterial accumulation (reducing the risk of respiratory infections), avoid skin irritation or pressure
sores, and ensure a high level of continued use. While full-face masks are an alternative, some users find
them intolerable and rely on chin straps to maintain therapy effectiveness. You state the chin straps are
specifically designed for use with the DreamStation™ CPAP Sleep Therapy devices and have no standalone
function. They are used with the headgear of the mask and the device and are specially made to ensure a
proper fit of the mask and to keep the pillow cushion in the patient's nostrils. No one would buy one unless
they owned the DreamStation™ CPAP Sleep Therapy device.
The applicable subheading for the Optilife chin straps 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.
Products of Mexico as provided by heading 9903.01.01 in Section XXII, Chapter 99, Subchapter III, U.S.
Note 2(a), HTSUS, other than products classifiable under headings 9903.01.02, 9903.01.03, 9903.01.04, and
9903.01.05, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At the time of entry,
you must report the applicable Chapter 99 heading, i.e. 9903.01.01, in addition to subheading 9019.20.0000,
HTSUS, listed above. Articles that are entered free of duty under the terms of general note 11 to the HTSUS
(U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set forth in subchapter XXIII of
Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be subject to the additional ad valorem
duties provided for in heading 9903.01.01. If your product is entered duty free as originating under the
USMCA, you must report heading 9903.01.04, HTSUS, in addition to subheading 9019.20.0000, HTSUS
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 Dominican
Republic 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.
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 Mexico are not
subject to reciprocal tariffs. At the time of entry, you must report the Chapter 99 heading applicable to your
product classification, i.e. 9903.01.27, in addition to subheading 9019.20.0000, HTSUS, listed above.
However, the additional duties imposed by heading 9903.01.01, 9903.01.25, or 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 Optilife chin straps 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 351578 (dated August 7, 2025), the sleep apnea masks including nasal masks and a nasal pillow
mask are used solely with 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 Optilife chin straps are accessories of the nasal masks and nasal pillow 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)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division