CLA-2-90:OT:RR:NC:N3:135
Robert Leo
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Avenue, Ste. 2405
New York, NY 10022
RE: The tariff classification of Philips InCourage System from China and Costa Rica
Dear Mr. Leo:
In your letter dated October 17, 2025, you requested a tariff classification ruling on behalf of your client,
Philips RS North America LLC.
The InCourage System is an airway clearance device with part numbers 500055-000 (made in China) and
500055-200 (made in Costa Rica). It is designed to assist in the loosening and clearing of excess mucus from
the lungs and airways, utilizing high-frequency chest wall oscillation (HFCWO), and is indicated when
external manipulation of the chest is the physician's treatment of choice for increasing the clearance of
mucus. The system consists of a therapy unit (i.e. air pulse unit), an inflatable vest, a set of interconnecting
hoses, a power cord, and a set of InCourage System bags designed and shaped to provide storage, protection,
portability, and safe organization of the aforementioned items. The therapy unit is the main control unit. It
creates the pulsating air compressions that are transferred to the vest and acts as the source of control for the
system. The vest inflates and the system actively vents out air in response to the patient’s breathing to aid in
the mobilization and clearance of bronchial secretions. Unlike other airway clearance therapy technologies,
the InCourage System features active venting and triangle waveforms. Active venting is designed to
immediately release air from the vest in response to the user’s breath, making the vest feel less constricted
and allowing a deeper inhale. The triangle waveform delivers a brief, intense, CPT-like thump on the chest,
which is designed to help thin mucus and aid its transport out of the airways.
The InCourage System promotes airway clearance and improves bronchial drainage utilizing HFCWO, also
known as vest therapy. It is used in the treatment of patients with chronic respiratory conditions that impair
mucus clearance, such as cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease (COPD), and
other chronic conditions where airway clearance is necessary. It utilizes HFCWO technology to help clear
mucus from the airways, improve lung function, and reduce the risk of respiratory infections. Its role is solely
for the alleviation or therapy of a chronic condition, specifically to promote airway clearance. It does not play
a role in diagnosis, prevention, monitoring, treatment, compensation for injury, support of anatomy, support
of physiological processes, or control of conception.
You assert that the InCourage System cannot be used for acute or transient disabilities. The high-frequency
chest wall oscillation functionality is a non-invasive method for airway clearance that improves the quality of
life for individuals with chronic respiratory diseases such as chronic pulmonary disease and cystic fibrosis.
You state that the system can only be obtained by patients with a physician’s prescription, provided they
exhibit a permanent or chronic physical disability. It is sold with a 2-year/500-hour use guarantee and one
vest garment of the patient’s choice. Although described as “not cumbersome,” the properties of an inflated
1.8-pound, 16- to 60-inch vest with vents that actively expel air in response to a patient's breathing are
distinguishable from articles for general public use. Therefore, its use by the general public is improbable.
You confirm that the InCourage System is specifically designed to produce vibrations that loosen and remove
mucus from the lungs for patients with chronic breathing conditions and is not useful to non-handicapped
people.
The applicable subheading for the InCourage System 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 heading 9903.01.24, 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, Harmonized
Tariff Schedule of the United Sates (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.
A person suffering from permanent or chronic breathing impairment is physically handicapped as that term is
defined in U.S. Note 4(a) to Subchapter XVII. You claim that the InCourage System is designed for and
dedicated solely to patients with chronic respiratory conditions that impair mucus clearance. Its purpose is to
help clear excess mucus from the lungs and airways. By clearing the airways, the device helps improve lung
function and reduce the risk of respiratory infections, making it easier for individuals to breathe. Based on the
information supplied, we find that the InCourage System qualifies 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