CLA-2:OT:RR:NC:N3:143
Parker White
Foley and Lardner LLP
777 E Wisconsin Ave, Ste 3800
Milwaukee, WI 53202-5300
RE: Eligibility for duty-free treatment under Nairobi Protocol concerning F&P 950 Respiratory Humidifier
System component parts from New Zealand.
Dear Mr. White:
In your letter dated March 10, 2026, you requested a classification tariff ruling on behalf of Fisher & Paykel
Healthcare Corporation Limited.
The items under consideration are the F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950
Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full
Face Mask (Item No. RT045), and the F&P 950 Sensor Cartridge (Item No. 950S02). These component parts
form the F&P 950 Respiratory Humidifier System and are designed to work together in the treatment of
patients with primarily permanent and chronic respiratory conditions. They are intended for use in hospitals,
sub-acute facilities, and long-term care facilities, under the supervision of qualified healthcare professionals.
The F&P 950 Respiratory Humidifier (Item No. 950JUS) is a respiratory device designed primarily for
patients with airway challenges resulting from chronic respiratory conditions such as asthma, cystic fibrosis,
COPD, interstitial lung disease, bronchiectasis, bronchopulmonary, dysplasia and chronic lung disease. The
device delivers heated and humidified medical gases with simultaneous oxygen delivery. It is intended for
use in patients whose conditions require prescription and supervision in a hospital setting.
The F&P 950 Adult/Pediatric Bi-Level/CPAP Circuit Kit (Item No. 950A61J) includes a dryline,
humidification chamber, inspiratory limb, and a disposable exhalation port. Together, these components form
a single limb circuit with an intentional leak for the delivery of non-invasive ventilation therapy. The kit
facilitates the delivery of humidified respiratory gases generated by the F&P 950 Respiratory Humidifier to
the selected Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
interface for administration to the patient. It is specifically designed as a required component part for the
F&P 950 Respiratory Humidifier System.
The F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045) is a single use mask intended for
delivery of non-invasive positive pressure ventilation therapy to spontaneously breathing patients with
respiratory failure or insufficiency. When used as part of the F&P 950 Respiratory Humidifier, the F&P 950
Adult/Pediatric Bi-Level/CPAP Circuit Kit, and the F&P Nivairo™ Vented Hospital Full Face Mask work
together to support patients with respiratory failure or insufficiency. Like the F&P 950 Adult/Pediatric
Bi-Level/CPAP Circuit Kit, the F&P Nivairo™ Vented Hospital Full Face Mask is specifically designed as a
necessary component part for the F&P 950 Respiratory Humidifier System.
The F&P 950 Sensor Cartridge (Item No. 950S02) contains incoming and outgoing gas temperature probes
and a flow sensor. It measures the gas temperature and flow rate for humidified gases generated by the F&P
950 Respiratory Humidifier. These sensors allow caregivers to measure and control the respiratory gases
delivered to patients suffering from permanent or chronic respiratory diseases. Like the F&P 950
Adult/Pediatric Bi-Level/CPAP Circuit Kit and the F&P Nivairo™ Vented Hospital Full Face Mask, the F&P
950 Sensor Cartridge is specifically designed as a necessary component part for the F&P 950 Respiratory
Humidifier System.
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.
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, Chapter 98, HTSUS. The F&P 950 Respiratory Humidifier
System is designed to support patients suffering from primarily permanent or chronic respiratory conditions.
CBP has classified similar respiratory humidifier products as eligible for duty-free treatment under
subheading 9817.00.96, HTSUS.
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 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 humidifiers, 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.
As such, the F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950 Adult/Pediatric
Bi-Level/CPAP Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full Face Mask (Item
No. RT045) and the F&P 950 Sensor Cartridge (Item No. 950S02) are designed for and essential for the
operation of the F&P 950 Respiratory Humidifier System. Based on the information provided and precedent
ruling, F&P 950 Respiratory Humidifier (Item No. 950JUS), the F&P 950 Adult/Pediatric Bi-Level/CPAP
Circuit Kit (Item No. 950A61J), the F&P Nivairo™ Vented Hospital Full Face Mask (Item No. RT045) and
the F&P 950 Sensor Cartridge (Item No. 950S02), are component parts specifically designed for or adapted
for use in the F&P 950 Respiratory Humidifier System and are eligible for the subheading 9817.00.96,
HTSUS.
Lastly, the F&P 950 Adult/Pediatric Ventilator Circuit Kit (Item No. 950A81J) will be addressed in a
separate correspondence.
The 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/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at
https://www.cbp.gov/trade/programs-administration/trade-remedies.
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 Forkan
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division