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N3128752020-07-29New YorkClassification

The tariff classification of two Specialized DreamStation 2 Button Keypads from China.

U.S. Customs and Border Protection · CROSS Database · 2 HTS codes referenced

Cross-Source Intelligence

Primary HTS Code

9019.20.0000

$321.8M monthly imports

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Court Cases

2 cases

CIT & Federal Circuit

Ruling Age

5 years

1 related ruling

Data compiled from CBP CROSS Rulings, Census Bureau Trade Data, CourtListener (CIT/CAFC) · As of 2026-05-04 · Updates monthly

Summary

The tariff classification of two Specialized DreamStation 2 Button Keypads from China.

Ruling Text

N312875 July 29, 2020 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9019.20.0000; 9817.00.96 Mr. Robert Leo Meeks, Sheppard, Leo & Pillsbury 570 Lexington Avenue, 24th Floor New York, NY 10022 RE: The tariff classification of two Specialized DreamStation 2 Button Keypads from China. Dear Mr. Leo: In your letter dated June 30, 2020, you requested a tariff classification ruling on behalf of Respironics, Inc. The merchandise under consideration are two Specialized DreamStation 2 Button Keypads (1116373 & 1143203). The components are designed as a button interface for the Respironics’ DreamStation devices, which provide continuous positive airway pressure (CPAP) and Bilevel positive airway pressure (BiPAP) therapy to treat patients with obstructive sleep apnea. Both keypads are three dimensional, rectangular, hard plastic panels designed to fit into the DreamStation devices. The panels are divided into two buttons with different lengths designated by a power icon and a ramp icon, respectively. The components do not contain metal contacts, nor electronics parts or accessories. When assembled, a user will press/engage the button to cause an action in the device. This component has two functions: 1) starts function of the therapy device, and 2) starts ramp feature of the therapy device. Both button keypads are identical, except for an accent ink along the rim. The plastic keypad 1143203 has a chrome edge to match other aesthetics on the DreamStation BiPAP AutoSV device. The 1116373 keypad has a white silk screen around the edge to match other aesthetics on the DreamStation CPAP and BiPAP devices. You state that the keypads are sold to be used solely for the CPAP and BiPAP devices for breathing-impaired persons and have a unique design to allow the DreamStation devices to function properly and will not fit on other devices. The applicable subheading for both Specialized DreamStation 2 Button Keypads (1116373 & 1143203) will be 9019.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[o]zone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The general rate of duty will be free. You also request consideration of the two Specialized DreamStation 2 Button Keypads for the DreamStation BiPAP AutoSV device and the DreamStation CPAP and BiPAP devices under the Nairobi Protocol. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982, established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. These tariff provisions specifically state that "[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 article" are eligible for duty-free treatment. U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS, states that, "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(b), subchapter XVII, Chapter 98, HTSUS, which establishes limits on classification of products in these subheadings, states as follows: (b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover-- (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. The primary issue is whether the two Specialized DreamStation 2 Button Keypads are “specially designed or adapted” for use in articles that is “specifically designed or adapted” for the use or benefit of handicapped persons within the meaning of the Nairobi Protocol. Although the legislative history of the Nairobi Protocol discusses the concerns of Congress that the design, modification or adaptation of an article must be significant so as to clearly render the article for use by handicapped individuals, no specific definition of these terms was established by Congress. See, Senate Report (Finance Committee) No. 97-564, September 21, 1982). See also, Headquarters Ruling Letter (HRL) 951004 dated March 3, 1992. Since it is difficult to establish a clear definition of what is “specially designed or adapted," various factors must be utilized on a case-by-case basis to determine whether a given article is "specially designed or adapted" within the meaning of this statute. Customs and Border Protection has determined that the CPAP devices designed for the treatment of obstructive sleep apnea qualify for duty-free treatment under subheading 9817.00.96, HTSUS. See NY ruling N059778 (dated May 29, 2009). The Bilevel positive airway pressure (BiPAP) which you state is “specifically designed” for individuals with profound chronic breathing issues is a similar device to treat patients with obstructive sleep apnea. Therefore, the DreamStation (BiPAP) devices also qualify for duty-free treatment under subheading 9817.00.96, HTSUS. In consideration of the information supplied, we believe that both Specialized DreamStation 2 Button Keypads (1116373 & 1143203) are necessary parts specially designed or adapted for use in the DreamStation devices and therefore eligible for classification in subheading 9817.00.96, HTSUS, which provides for “[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 article: [o]ther,” free of duty and the Merchandise Processing Fee (MPF). Note that the requirement that the importer prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010. Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or countervailing or dumping duties. 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 on World Wide Web at https://hts.usitc.gov/current. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division

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