OT:RR:CTF:VS H349574 AP
Sen Liang
Telesair, Inc.
199 Technology Dr., Suite 110
Irvine, CA 92618
RE: Bonhawa Respiratory Oxygen Platform Components; 9817.00.96, HTSUS
Dear Mr. Liang:
This is in response to your May 16, 2025 ruling request, submitted on behalf of Telesair,
Inc. (“importer” or “Telesair”), regarding the applicability of subheading 9817.00.96,
Harmonized Tariff Schedule of the United States (“HTSUS”), to four components (a heated
breathing circuit, a water chamber, a water chamber adapter, and a nasal cannula) used
exclusively with the Bonhawa Respiratory Oxygen Platform (“respiratory humidifier”), a
medical device developed by the importer.
FACTS:
The Bonhawa Respiratory Oxygen Platform is a high-flow oxygen respiratory humidifier
for the treatment of respiratory insufficiency for spontaneously breathing patients with warmed
and humidified respiratory gases. 1 It is intended for use by healthcare professionals in hospitals
and long-term care facilities and is only sold to hospitals, long-term care facilities, and
professional medical distributors.
You state that while the respiratory humidifier is capable of supporting both acute and
chronic respiratory conditions, the respiratory humidifier’s primary use is for long-term oxygen
therapy under prescription and supervision for chronic respiratory conditions such as chronic
obstructive pulmonary disease (“COPD”), idiopathic pulmonary fibrosis (“IPF”), and humidity
deficits in tracheostomy patients. You further state that even when the respiratory humidifier is
used acutely for respiratory failure often stemming from exacerbation of underlying chronic
1
See Bonhawa High Flow Oxygen Therapy (“HFOT”) System, https://www.telesair.com/product (last visited
Aug. 22, 2025). The respiratory humidifier has an extended flow range for severe respiratory insufficiency (up to 70
liters per minute).
diseases such as COPD, chronic heart failure, and interstitial lung diseases, “it is functioning as
part of a long-term care continuum, not as a one-time or wellness-based solution.”
The respiratory humidifier is only available by prescription and is registered as a Class II
medical device with the U.S. Food and Drug Administration (“FDA”). You explain that the
device is not available in general retail stores or marketed for wellness or general use, and all
promotional efforts are made through medical trade shows, clinical evaluation programs, and
hospital-based demonstrations.
The products under consideration in this ruling are a heated breathing circuit, a water
chamber, a water chamber adapter, and a nasal cannula, which are used exclusively with the
Bonhawa respiratory humidifier. These four components are packaged together in a sealed
plastic bag and referred to as a heated breathing circuit set.
The heated breathing circuit is a single-use tube assembly. The heated breathing circuit
delivers warm, humidified gas from the humidifier to the patient. It includes integrated sensors
and heating elements compatible only with the Bonhawa respiratory humidifier. It consists of a
single circuit tube measuring 200 cm in length with special connectors, integrated heating wires,
and a temperature sensor that are electronically regulated by the Bonhawa respiratory humidifier
to maintain target gas temperature and to avoid condensation. The sensor in the heated breathing
circuit is located close to the patient interface and provides monitoring of the gas temperature for
the device. This feature is designed for clinicians to monitor device temperature and safety. The
heated breathing circuit is connected to the Bonhawa respiratory humidifier via the water
chamber adapter.
The water chamber is a single-use water reservoir that holds sterile water for
humidification, which is molded to interface with the respiratory humidifier base. The water
chamber has a medical level plastic chamber wall, 12 cm diameter aluminum base, and Di(2-
ethylhexyl)phthalate (“DEHP”)-free tubing for auto water refill. During therapy, gas is passed
over the water surface or through a heated plate to produce humidified air. The chamber is
designed to fit precisely into the Bonhawa respiratory humidifier’s housing and heater plate.
The water chamber adapter connects the disposable water chamber, the main device, and
the breathing circuit. It ensures airtight operation and enables the system to heat and humidify
the gas stream. The adapter contains connection ports for both gas and electrical flow
monitoring and is designed to be replaced with each new water chamber and breathing circuit.
The nasal cannula is the patient interface for gas delivery and delivers humidified oxygen
or air to the nostrils. The nasal cannula has a 2.2 cm standard swivel connector with a neck
strap, gas delivery conduit, head strap, nasal prong interface, and retaining clip. It connects to
the end of the breathing circuit and is designed for comfortable extended wear. The cannula is
optimized for high flow therapy, with reinforced prongs and tubing designed to handle the
temperature and humidified air set by the Bonhawa respiratory humidifier.
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ISSUE:
Whether the heated breathing circuit, water chamber, water chamber adapter, and nasal
cannula, which are used exclusively with the Bonhawa respiratory humidifier, are eligible for
subheading 9817.00.96, HTSUS, treatment, and whether any additional tariffs will apply.
LAW AND ANALYSIS:
The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and
Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty-
free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and
Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the
implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and
9817.00.96, HTSUS.
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.” Thus, eligibility within
subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially
designed or adapted for the use or benefit of the blind or physically and mentally handicapped
persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b),
Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d
1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained:
The term “specially” is synonymous with “particularly,” which is defined as “to an
extent greater than in other cases or towards others.” Webster’s Third New
International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for
“designed” is something that is “done, performed, or made with purpose and intent
often despite an appearance of being accidental, spontaneous, or natural.”
Webster’s Third New International Dictionary 612 (unabr. 2002).
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. You explain that while the respiratory humidifier is
capable of supporting both acute and chronic respiratory conditions, the respiratory humidifier’s
primary use is for long-term oxygen therapy under prescription and supervision for chronic
respiratory conditions such as COPD, IPF, and humidity deficits in tracheostomy patients. You
further state that even when the respiratory humidifier is used acutely for respiratory failure often
stemming from exacerbation of underlying chronic diseases such as COPD, chronic heart failure,
and interstitial lung diseases, “it is functioning as part of a long-term care continuum.”
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The U.S. Court of Appeals for the Federal Circuit (“CAFC”) clarified 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. This definition of ‘specially
designed’ is consistent with factors that Customs uses in discerning for whose use and benefit a
product is ‘specially designed’ … we adopt them in our analysis ….” Sigvaris, 899 F.3d at
1314-15. U.S. Customs and Border Protection (“CBP”) examines the following five factors
adopted by the CAFC in Sigvaris, 899 F.3d at 1314-15: (1) physical properties of the article
itself (e.g., whether the article is easily distinguishable in design, form and use from articles
useful to non-handicapped persons); (2) presence of any characteristics 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) importation by manufacturers or distributors recognized
or proven to be involved in this class or kind of articles for the handicapped; (4) sale in specialty
stores that serve handicapped individuals; and (5) indication at the time of importation that the
article is for the handicapped. See also Treasury Decision 92-77, 26 Cust. B. & Dec. 240 (1992).
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. The Bonhawa respiratory humidifier is specially
designed for the use or benefit of persons with chronic respiratory conditions such as COPD,
which limit one or more major life activities, including a person’s ability to breathe. The
respiratory humidifier functions “as part of a long-term care continuum” and its primary use is
for long-term oxygen therapy for chronic respiratory conditions. The device is not available in
general retail stores and is not marketed for wellness or general use. It is available by
prescription only and all promotional efforts are made through medical trade shows, clinical
evaluation programs, and hospital-based demonstrations. 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. None of the exclusions listed under U.S. Note 4(b) apply to the Bonhawa
Respiratory Humidifier. Therefore, we find that the respiratory humidifier is eligible for
subheading 9817.00.96, HTSUS treatment.
Further, CBP has determined that component parts that are specifically designed to work
exclusively with a device classifiable in subheading 9817.00.96, HTSUS, are eligible for
subheading 9817.00.96, HTSUS treatment. In New York Ruling Letter (“NY”) N313225, dated
July 27, 2020, CBP held that a power supply and battery designed to work exclusively with a
ResMed CPAP machine and Astral series of ventilators specifically designed for individuals with
profound chronic breathing issues were eligible for subheading 9817.00.96, HTSUS treatment.
Also, in NY N314820, dated Oct. 16, 2020, a printed circuit board designed, manufactured, and
used exclusively with a respiratory therapy machine designed to assist people with chronic
breathing issues such as obstructive sleep apnea and respiratory insufficiency was eligible for
subheading 9817.00.96, HTSUS treatment as a part specially designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
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Here, the four single-use heated breathing circuit, water chamber, water chamber adapter,
and nasal cannula are used exclusively with and are essential for the operation of the Bonhawa
respiratory humidifier. Without them the device cannot function. All four component parts are
designed and marketed specifically for use with the Bonhawa respiratory humidifier and are not
intended for general purpose use with other respiratory devices. Accordingly, the instant heated
breathing circuit, water chamber, water chamber adapter, and nasal cannula are parts specially
designed or adapted for the use in the Bonhawa respiratory humidifier and are eligible for
subheading 9817.00.96, HTSUS treatment and no additional duties will apply under the HTSUS
currently in effect.
HOLDING:
The heated breathing circuit, water chamber, water chamber adapter, and nasal cannula
are eligible for subheading 9817.00.96, HTSUS treatment, as parts that are specially designed or
adapted for use in the Bonhawa respiratory humidifier, which is “specially designed or adapted
for the use or benefit of the blind or other physically or mentally handicapped persons” and no
additional duties will apply under the current HTSUS.
Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the
assumption that all of the information furnished in connection with the ruling request and
incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
complete in every material respect. The application of a ruling letter by [CBP] field office to the
transaction to which it is purported to relate is subject to the verification of the facts incorporated
in the ruling letter, a comparison of the transaction described therein to the actual transaction,
and the satisfaction of any conditions on which the ruling was based.”
A copy of this ruling letter should be attached to the entry documents filed at the time this
merchandise is entered. If the documents have been filed without a copy, this ruling should be
brought to the attention of the CBP officer handling the transaction.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
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