CLA-2-90:OT:RR:NC|:N3:143
Sen Liang
Telesair Inc
199 Technology Dr., Suite 110
Irvine, CA 92618
RE: Eligibility for duty-free treatment under Nairobi Protocol concerning Bonhawa Respiratory Humidifier
System component part from China.
Dear Mr. Liang:
In your letter dated June 1, 2026, you requested a tariff classification ruling.
The item under consideration is the Bottom Outer Housing (Part No.CC0002). Separate rulings will address
Power Supply Board BH-02 (Part No. CC0036), Heater Plate 110V (Part No. CC0047-01), Heater Plate
220V (Part No. CC0047-02), and Heater Plate Mesh (Part No. 0062).
The Bottom Outer Housing (Part No. CC0002) is the bottom component of the Bonhawa Respiratory
Humidifier case. Based on the images provided in your email dated 06/08/2026, the Bottom Outer Housing is
imported without any attachments, cables, or electrical components. It is injection-molded from a
high-performance, halogen-free PC/ABS alloy and is specifically designed for exclusive use with the
Bonhawa Respiratory Humidifier.
As noted in Headquarters Ruling Letter (“HQ”) H349574, August 25, 2025, 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. 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.
The applicable subheading for the Bottom Outer Housing (Part No. CC0002), will be 9019.20.0000,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Ozone therapy, oxygen
therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus and parts and
accessories thereof.” The rate of duty will be free.
In your submission you requested consideration of a classification under 9817.00.96, 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 9817.00.60, 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 United States 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 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.
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
Headquarters Ruling Letter (“HQ”) H349574, August 25, 2025, CBP held that a heated breathing circuit, a
water chamber, a water chamber adapter and a nasal cannula, which are used exclusively with the Bonhawa
Respiratory Humidifier, and designed for individuals with chronic respiratory conditions such as COPD,
chronic heart failure and interstitial lung disease were eligible for subheading 9817.00.96, HTSUS treatment.
The Bottom Outer Housing (Part No. CC0002) is also a component part used exclusively with the Bonhawa
Respiratory Humidifier and therefore qualifies for duty-free treatment under the Nairobi Protocol.
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 Dionisia Melman at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division