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 a humidifier water tank with lid, water tank, and heat plate assembly from
China and Mexico
Dear Ms. Abraham:
In your letter dated October 20, 2025, on behalf of your client, Philips RS North America LLC, you
requested a tariff classification ruling for four items. One of them, a disposable ultra-fine filter, will be
addressed under a separate correspondence.
Part number 1116038, Nirvana RoHS Heater Plate Assembly DS, consists of a heater plate, a wiring harness,
and wires bonded to the heater plate to produce heat for the humidifier tank. It is specially designed for, and
solely for use in, the DreamStation CPAP (continuous positive airway pressure) and BiPAP (bilevel positive
airway pressure) devices. The size and shape of the heater plate and wire harness is unique to the
DreamStation design. This heater plate assembly does not fit any other design and is not an off-the-shelf
assembly. Once the heater plate wire harness is plugged in and the humidifier tank is filled to the appropriate
water level, the heater plate assembly heats the water to create humidified, warm air for the patient. The
warm, humidified air is a comfort feature for the user. The heater plate assembly is produced in China
according to Philips’ design specifications, which include the heater plate assembly design, component
selection (BOM), power or signal connectivity, standards compliance, and form factor.
Part number 1142832, DS2 Humidifier Water Tank with Lid RP, is an assembled humidifier tank consisting
of a tank bottom, a seal ring, a tank top, and a tank latch. You state that it is used with DreamStation 2 (DS2)
CPAP and BiPAP devices. The size and shape of the DS2 humidifier tank is designed to fit the DreamStation
device assembly. The DS2 humidifier tank provides humidified or warm, moist air for the patient or customer
who fills the humidifier tank with water. When the humidifier is attached to the device, the heater plate on
the humidifier can be heated by the device, which then heats the water. It serves as a replacement part if the
humidifier tank is lost or damaged. You state that the humidifier water tank is a custom design that only fits
the DS2 device and is not an off-the-shelf component assembly. It is made in China.
Part number 1122520, RP water tank, is an assembled replacement water tank (without the lid) used if the
water tank is damaged. It is used with DreamStation CPAP and DreamStation BiPAP devices. The water tank
helps produce warm, humidified air for the patient. The water tank consists of a tank top and a tank bottom.
You state that the water tank is a unique design and only works with DreamStation devices. The size and
shape of the water tank is designed for a good fit to the DreamStation humidifier base. This is not an
off-the-shelf component; it is produced in Mexico.
In your letter, you propose classification of the heater plate assembly under subheading 9019.20.0000,
Harmonized Tariff Schedule of the United States (HTSUS), which provides, in relevant part, for parts of
therapeutic respiration apparatus. We disagree with the suggested classification. Chapter 90 Note 2 (a) states
“that parts and accessories which are goods included in any of the headings of this chapter or of chapter 84,
85 or 91 (other than heading 8487, 8548 or 9033), are in all cases to be classified in their respective
headings.” The heater plate assembly is a good specifically provided for under a heading in Chapter 85.
Furthermore, Additional U.S. Rules of Interpretation Note 1(c) states a provision for parts of an article covers
products solely or principally used as a part of such articles but a provision for “parts” or “parts and
accessories” shall not prevail over a specific provision for such part or accessory. Therefore, based on these
rules, subheading 9019.20.0000, HTSUS, will not apply.
The applicable subheading for the heater plate assembly will be 8516.10.0080, HTSUS, which provides, in
pertinent part, for “[e]lectric instantaneous or storage water heaters and immersion heaters…: [e]lectric
instantaneous or storage water heaters and immersion heaters: [o]ther water heaters and immersion heaters.”
The general rate of duty is free.
The applicable subheading for the humidifier water tank with the lid and the water tank will be 9019.20.0000,
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 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 subheadings 9019.20.0000 and 8516.10.0080, 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 and 8516.10.0080, 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.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 8516.10.0080, HTSUS, unless specifically excluded, are subject to an additional 7.5 percent ad
valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.15,
in addition to subheading 8516.10.0080, HTSUS, listed above.
However, the additional duties imposed by heading 9903.01.01, 9903.01.24, 9903.01.25, or 9903.88.15 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.
Customs and Border Protection has determined that the CPAP devices designed to treat patients with chronic
sleep apnea qualify for duty-free treatment under subheading 9817.00.96, HTSUS. See NY ruling N059778
(dated May 29, 2009). Online research indicates that BiPAP devices are also used to treat sleep apnea,
particularly when CPAP therapy is not sufficient or well-tolerated. While 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. You assert that the humidifier water
tank with the lid, water tank, and heater plate assembly are integral component parts of the DreamStation and
DreamStation 2 CPAP and BiPAP devices, which deliver CPAP and BiPAP therapy to chronic sleep apnea
patients. These parts are specially designed for and marketed exclusively for the DreamStation devices, and
are integral to their successful function. Based on the information provided, it is our opinion that these items
are parts specially designed for use in the DreamStation and DreamStation 2 CPAP and BiPAP devices 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 humidifier water tank
with the lid and water tank, please contact National Import Specialist Fei Chen at [email protected].
Questions concerning the heater plate assembly should be addressed to National Import Specialist Michael
Chen at [email protected].
Sincerely,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division