CLA-2-90:OT:RR:NC:N1:105
9817.00.96
Juan Moreno
Sandler, Travis and Rosenberg, PA
414 Jackson Street, Suite 200
San Francisco, CA 94111
RE: The tariff classification of Hemodialysis System Console components from China
Dear Mr. Moreno:
In your letter dated July 18, 2025, on behalf of your client, Outset Medical inc., you requested a tariff
classification ruling. Descriptive literature was provided for our review.
The three items under consideration are all described as parts designed for the Tablo Hemodialysis System
Console, which is the core component of the Outset Medical Tablo System, a mobile, all-in-one hemodialysis
machine designed for use in various care settings, including hospitals and homes. It integrates water
purification and dialysate production, eliminating the need for separate equipment. The console features a
touchscreen interface, wireless data communication, and automated functions to simplify dialysis treatment.
The first item under consideration is described as a pressure sensor (part number PN-0006362), which is a
spare component designed exclusively for the Tablo Hemodialysis System Console and is utilized for
maintenance and repair of the system. This precision sensor monitors and transmits the fluid pressure
upstream of the ultrafilter, a key operational parameter necessary for the safe and effective production of
dialysate and overall dialysis treatment. The sensor’s functionality is wholly dependent on its integration
within the Tablo Console’s custom-designed manifold, where it is securely housed to ensure accurate
pressure measurement. In addition, it requires direct connection to the console’s proprietary electronics and
embedded software, which processes and interprets the pressure data communicated via a serial interface.
The sensor is neither interchangeable with, nor adaptable for use in, any other dialysis systems or general
medical equipment. The pressure sensor is connected to the Tablo Console dialysate delivery breakout circuit
board via an Outset specified 6-pin connector that mates with a matching connector on the circuit board. The
signals from the pressure sensor are routed via ribbon cables to the Dialysis Sensor circuit board, which
includes the circuitry and software to communicate with the sensor.
The second item under consideration is described as the power supply module (PN-0006208), which is a
medical-grade, replacement component designed exclusively for use in the Tablo Hemodialysis System
Console. This module converts residential alternating current (AC) power from a standard wall outlet into a
stable 24V, 1100W, direct current (DC) output, specifically calibrated to meet the power requirements of the
Tablo Console’s electronic and electromechanical systems. The Power Supply Module is engineered with
electrical specifications tailored for the operational demands of the Tablo Console and is not compatible with
other medical devices or general-purpose equipment. To function, the module requires connection through
three cable harnesses that link the power supply to both the AC input source and the console’s internal power
architecture. Proprietary software monitors the power supply for faults and turns it on and off to perform
self-tests of the power supply.
The third item under consideration is described as the Base, degas chamber (PN-0004592), which is also a
spare part designed exclusively for the Tablo Hemodialysis System Console, used specifically in the repair
and maintenance of the system’s dialysate preparation process. Within the console, the degas chamber
performs a critical function by removing entrained air from purified water prior to the formulation of
dialysate, an essential step to ensure patient safety during hemodialysis treatment. The Base is a
custom-engineered, injection-molded plastic manifold, purpose-built to support this degassing operation
within the tightly controlled fluidic architecture of the Tablo Console. The Base is designed to interface
exclusively with the mating degas chamber body. The Base, degas chamber’s dimensional specifications,
material composition, and functional characteristics are unique to the system and have no general utility
outside of the Tablo platform.
The applicable subheading for the pressure sensor (part number PN-0006362) will be 9026.20.4000, HTSUS,
which provides for “Instruments and apparatus for measuring or checking the flow, level, pressure or other
variables of liquids or gases (for example, flow meters, level gauges, manometers, heat meters), excluding
instruments and apparatus of heading 9014, 9015, 9028 or 9032; parts and accessories thereof: For measuring
or checking pressure: Electrical.” The general rate of duty will be free.
The applicable subheading for the power supply module (PN-0006208) will be 8504.40.9540, HTSUS, which
provides for “Electrical transformers, static converters…: Static converters: Other: Rectifiers and rectifying
apparatus: Power Supplies: Other.” The general rate of duty will be free.
The applicable subheading for the Base, degas chamber (PN-0004592) will be 9018.90.7570, HTSUS, which
provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including
scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories
thereof: Other instruments and appliances and parts and accessories thereof: Other: Electro-medical
instruments and appliances and parts and accessories thereof: Other: Other: Parts and accessories of dialysis
instruments and apparatus.” 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 subheadings 9026.20.4000, 8504.40.9540, and 9018.90.7570, 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 subheadings 9026.20.4000, 8504.40.9540, and 9018.90.7570, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheadings 9026.20.4000 and 9018.90.7570, 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 subheadings 9026.20.4000 and 9018.90.7570, HTSUS, listed
above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 8504.40.9540, 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 8504.40.9540, HTSUS, listed above.
The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status
of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background
information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may
refer to the relevant parts of the USTR and CBP websites, which are available at
https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and
https://www.cbp.gov/trade/remedies/301-certain-products-china respectively.
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 oneself, 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 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.
In Headquarters Ruling HQ 964676 (dated January 7, 2002), CBP determined that the specially produced
P.E.S./P.E.T. bundles used in dialyzers for the treatment of chronic renal failure qualified for duty free
treatment under subheading 9817.00.96, HTSUS. In the ruling, CBP confirmed that people who suffer from
end-stage renal failure were considered handicapped, and articles specifically designed almost exclusively for
their benefit were classifiable as articles for the handicapped, as established in Travenol Laboratories, Inc. v.
United States, 813 F. Supp. 840, 844 (CIT 1993). In that case, while the dialyzers incorporating these fiber
bundles could be used for acute or transient renal failure, their recommended use is in the treatment of
patients with chronic renal failure. Applying the five factors to determine the meaning of the phrase
“specially designed or adapted,” CBP granted duty free treatment for the fiber bundles under subheading
9817.00.96, HTSUS. Based on the information supplied regarding the designed, function, and primary use of
the Tablo Hemodialysis System and the relevant precedent, it was determined in New York Ruling N345258
(dated February 7, 2025) that a secondary classification will apply for Tablo Console in subheading
9817.00.96, HTSUS.
Subheading 9817.00.96, HTSUS, also includes “parts or accessories” of the articles that are specially
designed or adapted for the handicapped. We find that each of the components listed above are proprietary
components of the Tablo Console and cannot be used with other devices. Additionally, the components are
required for the Tablo Console to operate and thus the need for these specific replacement parts. As such, per
Chapter 90 Note 2(a), we find the pressure sensor (part number PN-0006362), the power supply module
(PN-0006208), and the Base, degas chamber (N-0004592) are specifically designed for use in the Tablo
Console as a “part” of that article and eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
Please note that the additional duties imposed by headings 9903.88.01, 9903.88.03, 9903.01.24, and
9903.01.25 do not apply to goods for which entry is properly claimed under a provision of chapter 98 of the
HTSUS, except for goods entered under headings 9802.00.40, 9802.00.50, 9802.00.60, and 9802.00.80. For
headings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the value of repairs,
alterations, or processing performed abroad, as described in the applicable heading. For heading 9802.00.80,
the additional duties apply to the value of the article less the cost or value of such products of the United
States, as described in heading 9802.00.80.
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 Jason Christie at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division