CLA-2-90:OT:RR:NC:N3 135
Peter Rother
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441
RE: The tariff classification of reusable pulse oximetry soft sensors from an unidentified country.
Dear Mr. Rother:
In your letter dated May 21, 2025, you requested a tariff classification ruling. A sample was received and will
be returned.
Nonin Reusable Pulse Oximetry Soft Sensors (Model 8000SM2, part number 6836-801 and Model
8000SM-WO2, part number 6836-800) are fingertip transmittance sensors comprised of a molded silicone
boot that contains sensor optics, a cable, and a sensor connector. Both models are only compatible with Noni
n Model 3150 Pulse Oximeter. In use, the sensor connector of the reusable soft sensor will be inserted into
the sensor port of the Nonin Model 3150 Pulse Oximeter and the sensor boot will be attached to the patient’s
finger or toe. The Nonin Model 3150 Pulse Oximeter is a small wrist-worn device indicated for use in
measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin and pulse rate of adult
and pediatric patients. It is intended for spot-checking and/or data collection and recording of patients who
are well or poorly perfused. The intended use environments are sleep and pulmonary rehab labs, surgical
recovery, critical care, emergency room, long-term case, home use, and mobile units. The Nonin Reusable
Pulse Oximetry Soft Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of
adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including
operating room, surgical recovery, critical care, emergency room, long-term care, home use, and mobile
environments.
Nonin Model 3150 Carrying Case is constructed with an outer surface of man-made textile materials. It
features a main enclosure and a mesh enclosure. It also has a hook and loop strap on the back and the Nonin
name and logo on its front side.
The applicable subheading for both models of Nonin Reusable Pulse Oximetry Soft Sensors will be
9018.19.9560, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments
and appliances used in medical, surgical, dental or veterinary sciences …: [e]lectro-diagnostic apparatus …:
[o]ther: [o]ther: [o]ther: [p]arts and accessories.” 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 9018.19.9560, 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 from all countries
will be subject to an additional10 percent ad valorem rate of duty. 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
9018.19.9560, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 9018.19.9560, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad
valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e.,
9903.88.01, in addition to subheading 9018.19.9560, HTSUS, listed above.
The applicable subheading for the carrying case will be 4202.92.9100, HTSUS, which provides for other
containers and cases, with outer surface of sheeting of plastic or of textile materials, other, other, with outer
surface of textile materials, of man-made fibers (except jewelry boxes of a kind normally sold at retail with
their contents). The general rate of duty will be 17.6 percent ad valorem.
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 4202.92.9100, 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 from all countries
will be subject to an additional 10 percent ad valorem rate of duty. 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
4202.92.9100, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 4202.92.9100, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad
valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.03,
in addition to subheading 4202.92.9100, HTSUS, listed above.
In your submission you requested consideration of a secondary 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 9817.00.96, 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.
The Nonim Model 3150 Pulse Oximeter and Nonin Reusable Pulse Oximetry Soft Sensors are designed for
the use or benefit of a variety of people including those with an acute or transient disability in various
environments including operating rooms, surgical recovery, critical care, emergency room, long-term care,
home use, and mobile environments. They are not specially designed or adapted for the use or benefit of the
handicapped. In addition, the Nonim Model 3150 Pulse Oximeter is considered a diagnostic article.
“Diagnostic articles are those used to assist in determining the presence of disease or other ailments.” See
T.D. 92-77, 26 Cust. Bull. & Dec. 249, 250 (1992). Diagnostic articles have been defined as articles that
"assist a health professional to detect the signs and symptoms of a condition or disease.” See Trumpf Med.
Sys., Inc. v. United States, 34 CIT 1404, 1417, 753 F. Supp. 2d 1297, 1308 (2010). The Nonim Model 3150
Pulse Oximeter is used to measure blood oxygen saturation levels and pulse rate, which can be used to assist
in determining the presence of certain diseases or other ailments, particularly those affecting oxygen levels in
the blood. It is classified as an electro-diagnostic device in subheading 9018.19.9550, HTSUS. As such, it
will be precluded from subheading 9817.00.96, HTSUS, per U.S. Note 4(b)(iii), subchapter XVII, Chapter
98. Since the Nonim Model 3150 Pulse Oximeter does not qualify for duty-free treatment under the Nairobi
Protocol, the Nonin Reusable Pulse Oximetry Soft Sensors and Nonin Model 3150 Carrying Case do not
qualify because they are not specially designed or adapted for use in a qualifying article.
Your inquiry does not provide enough information for us to give a classification ruling on the wristband,
LCD display, and adapter cable. Your request for a classification ruling should include the following
information:
Regarding the wristband:
Provide the dimensions of the item.
Identify all components used in the manufacture of the item including fiber content by percentage.
Explain how the item is constructed including whether the fabric is woven, knitted, or nonwoven and
whether the fabric is dyed or printed.
Identify how the edges are finished on the item, e.g. cut to size, heat seal, compressed, hemmed, rolled
edges, welded, etc.
State if the item is impregnated, coated, or covered on one or both sides. If coated, state what the
coating material is and whether it is colored. Indicate the respective weights, in grams per square
meter. If coated with plastic indicate whether the plastic is cellular or compact.
Verify if the item is made up of multiple layers. Please provide separate information for each layer and
where the layer is located.
Describe the method of coating, covering, impregnating or laminated any material, if indeed it is. For
example, is a textile fabric combined with a pre-existing sheet or film of plastic or is it coated with
plastic in liquid form?
Regarding the LCD display:
Provide a legible, labeled, exploded-view diagram that identifies all internal and external components
for each component of this LCD. List their functions.
What electronics are on the LCD at the time of importation. Does it contain driver or control
electronics? List the functions of each electronic component.
What types of connectors, if any, are on the LCD at time of importation?
Does the display have all the circuitry needed to display the data?
What can it display at the time of importation?
Could the LCD display be used with anything other than the subject pulse oximeter?
Regarding the adapter cable:
Provide a complete description of the signals carried and/or transmitted by the cable.
Is the cable meant to power the oximetry device?
Is the cable meant to transfer data from one point to another? What data is transferred, specifically?
Provide a cross section of the cable detailing the inner construction. If the cable contains a PCBA,
please provide a detailed photographic representation and description of this PCBA detailing its
function.
Does the cable simply transfer an electrical signal from one point to another? Does it contain any
sensors that initiate or create a signal? Does it alter or change the electrical signal in any way?
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 heading 9018, please
contact National Import Specialist (NIS) Fei Chen at [email protected]. If you have any questions
regarding heading 4202, please contact NIS Vikki Lazaro at [email protected].
Sincerely,
(for)
Steven A. Mack
Director
National Commodity Specialist Division