The tariff classification of a continuous glucose monitor secondary alarm system from China

N360490
April 20, 2026
CLA-2-85:OT:RR:NC:N2:209
CATEGORY: Classification
TARIFF NO.: 8531.20.0020; 9817.00.96
Chris Fawcett Custom Type One 4381 Hudson Drive, #185 Stow, OH 44224 RE: The tariff classification of a continuous glucose monitor secondary alarm system from China Dear Mr. Fawcett: In your letter dated April 7, 2026, you requested a tariff classification ruling. The merchandise under consideration is identified as the SugarPixel Continuous Glucose Monitoring (CGM) Secondary Alarm System. The SugarPixel is described as a tabletop electronic device consisting of a plastic housing, an LCD display panel and a speaker. This device receives real-time glucose data for people with diabetes via Wi-Fi from cloud-based services provided by CGM manufacturers, such as Dexcom, Libre, Nightscount, etc. The data which is transmitted to the SugarPixel has already been measured by the user’s CGM sensor and is made available to the user through their primary CGM mobile device application. The SugarPixel serves exclusively as a blood sugar monitoring/secondary alarm device, providing supplemental audio and visual alerts regarding the user’s glucose levels. In your ruling request, you suggest that the correct classification for the SugarPixel should be 8531.80.90, Harmonized Tariff Schedule of the United States (HTSUS). We disagree. It is CBP’s position that articles which display limited information that is easily understood by the user (i.e. indicator panels) are classified within their own specific subheading in heading 8531, HTSUS. The applicable subheading for the SugarPixel CGM Secondary Alarm System will be 8531.20.0020, HTSUS, which provides for Electric sound or visual signaling apparatus (for example, bells, sirens, indicator panels, burglar or fire alarms), other than those of heading 8512 or 8530; parts thereof: Indicator panels incorporating liquid crystal devices (LCD's) or light emitting diodes (LED): Incorporating LCD’s. The general 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 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: “Articles 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 . . . Other.” 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. Based on the information supplied, the SugarPixel CGM Secondary Alarm System does satisfy the 5 factors set out by CBP. The device is used exclusively as a blood sugar monitoring/warning system and is not capable of use for non-diabetic functions. As a result, it is the opinion of this office that a secondary classification will apply in subheading 9817.00.96, HTSUS. 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 Steven Pollichino at [email protected].
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division