CLA-2-90:OT:RR:NC:N3 135
Juan Moreno
Sandler, Travis & Rosenberg, P.A.
414 Jackson St., Suite 200
San Francisco, CA 94111
RE: The tariff classification of a Tablo Console, Tablo Cartridge, and TabloCart from Mexico
Dear Mr. Moreno:
In your letter dated January 18, 2025, you requested a tariff classification ruling on behalf of Outset Medical Inc. Supplemental information was summitted by email, dated January 30, 2025.
The products under consideration are a “Tablo Hemodialysis System Console,” a “Tablo Cartridge,” and a “TabloCart.” The Console and the Cartridge constitute the Tablo Hemodialysis System. The Cart is an optional component of the system. The Tablo Hemodialysis System performs a critical medical function by removing waste, toxins, and excess fluids from the blood, replicating the natural filtration performed by healthy kidneys. It is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. The system is also indicated for use in the home. You claim that while the Tablo Hemodialysis System Console could be used for acute or transient renal failure, the vast majority (approximately 90 percent) of dialysis patients that utilize the Tablo console suffer from end-stage renal disease (chronic renal failure). You state “[t]he primary difference between a machine designed for acute kidney failure (acute kidney injury, AKI) and one designed for end-stage renal disease (ESRD) lies in their purpose, usability, treatment frequency, and patient condition.” “Although the same dialysis machines can be used for both acute kidney injury (AKI) and end-stage renal disease (ESRD), they are ultimately designed with chronic kidney failure patients in mind.” You explain that standard hemodialysis machines are built for long-term, repetitive use to manage ESRD patients. While these machines can be adapted to treat AKI patients in certain settings, the primary focus of their design is to support sustained, ongoing treatment rather than temporary kidney recovery. “Conversely, continuous renal replacement therapy (CRRT) machines are specifically optimized for critically ill patients with AKI.” “Despite some overlap in machine usage, the distinction in their intended purpose remains crucial in tailoring treatment to the patient's condition. Outset Medical’s Tablo machine, [which is the subject of this ruling], is not cleared for continuous renal replacement therapy (CRRT).”
The Tablo Console is a single module consisting of multiple fluidic systems that perform the activities of a water purification system and a conventional dialysis delivery system and has four lockable wheels. The Tablo Cartridge consists of arterial and venous bloodlines, a saline line, an infusion line, infusion ports, clamps, a saline spike, a venous transducer protector, a venous pressure transducer interface elbow, a venous drip chamber, an arterial pressure pod, a blood return saline router, and a T-connector connected in a specially designed plastic housing. The cartridge is a single use, disposable cartridge that is inserted onto the front panel of the Console for each dialysis treatment. It is an integral piece of the dialysis process, necessary to complete hemodialysis, and compatible only with the Tablo Hemodialysis System. The TabloCart is available in two configurations. The TabloCart with Storage Drawer (an empty drawer for storing supplies) consists of a plastic platform, a drawer, and four 360-degree wheels with wheel locks. The TabloCart with Prefiltration Drawer consists of a plastic platform, a power cord, a prefiltration drawer (a drawer with filters and a booster pump for preparing source water before it enters the Console), water connections, four 360-degree wheels with wheel locks, and indicator lights. The Tablo Console is mounted on the TabloCart that raises the height of the Tablo console and aids in overall system mobility of the Tablo console. The Tablo Hemodialysis System is designed to operate as intended with or without use of the optional cart and the cart is compatible only with the Tablo Hemodialysis System.
The applicable subheading for the Tablo Console will be 9018.90.7520, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments 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: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [e]lectro-medical instruments and appliances and parts and accessories thereof: [o]ther: [o]ther: [d]ialysis instruments and apparatus.” The rate of duty will be free.
The applicable subheading for the Tablo Cartridge will be 9018.90.7570, HTSUS, which provides for [i]nstruments 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: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [e]lectro-medical instruments and appliances and parts and accessories thereof: [o]ther: [o]ther: [p]arts and accessories of dialysis instruments and apparatus. The rate of duty will be free.
The applicable subheading for the TabloCart in both configurations will be 9402.90.0020, HTSUS, which provides for “[m]edical, surgical, dental or veterinary furniture … : [o]ther: [o]ther.” The rate of duty will be free.
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 9817.00.60, 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 is the opinion of this office that a secondary classification will apply for Tablo Console and the TabloCart 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. Whether the Tablo Cartridge qualifies as a part of the Tablo Console under subheading 9817.00.96, HTSUS, we consider whether it would be considered a part of the Tablo Console under a general analysis of the classification of parts. The Tablo Cartridge is an integral part to the dialysis process, necessary to complete hemodialysis, and compatible only with the Tablo Console. “It is designed, in conjunction with the Tablo console, to remove the patients’ blood, pass this blood over the filter media to remove the toxins.” As such, we find the Tablo Cartridge that is specially designed for use in the Tablo Console is a “part” of that article and also eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
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 Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division