Application for Further Review of Protest No. 3501-25-103394; Articles for the Handicapped; Subheading 9817.00.96; Flexitouch Plus Power Supplies

H347000 January 21, 2026 CLA-2 RR:CTF:VSP JH CATEGORY: Classification TARIFF NO.: 9817.00.96 Mark Neville International Trade Counsellors 2153 Clementine St. Naples, FL 34120 RE: Application for Further Review of Protest No. 3501-25-103394; Articles for the Handicapped; Subheading 9817.00.96; Flexitouch Plus Power Supplies Dear Mr. Neville: This is in response to your Application for Further Review (“AFR”) of Protest Number 3501-25-103394. International Trade Counsellors, on behalf of Nextern Inc. (“Protestant”), timely filed the AFR on February 6th, 2025. The AFR challenges the liquidation of eight entries of power supplies for the Flexitouch Plus device entered on November 5, 2024, November 15, 2024, and January 31, 2025, which were classified under subheading 8504.40.95, Harmonized Tariff Schedule of the United States (“HTSUS”). The power supplies also received an additional section 301 duty of 25 percent under subheading 9903.88.03, HTSUS. The Protestant acknowledges the classification under 8504.40.95, HTSUS, but asserts that the subject power supplies should be exempt from the additional duty as they are eligible for classification under subheading 9817.00.96, HTSUS. FACTS: The product at issue is described as a prescription-based, power supply that is produced by Fuhua, a Chinese manufacturer, and is custom-made to Nextern’s specifications for use with the Flexitouch Plus device. The power supply has a cord that is approximately 300mm long, and includes a green LED light that has a purpose of indicating to the patient that the cord is plugged in. It is also intended to be used with 120 Volt AC or 230 Volt AC outlets. The Protestant has indicated that Fuhua does not sell this power supply model to any other company as its use is confined to Flexitouch medical appliances. The Flexitouch Plus device is an advanced pneumatic compression device that is used by patients under a doctor’s care for treatment to increase lymphatic flow by stimulating the lymphatic system. It helps direct and move excess fluid from an impaired lymphatic region to 2 healthy regions, where fluid can be absorbed and processed naturally by the patient’s body. It is designed to treat patients suffering from lymphedema, chronic edema, or chronic wounds. It is designed for at-home treatment to help improve the patient’s health and quality of life through daily usage. The Protestant claims that their case is consistent with that of New York Ruling (“NY”) N311891 where U.S. Customs and Border Protection (“CBP”) held that two power supplies (One AC/DC and the other DC/DC) classified under 8504.50.95 and 8504.90.85, HTSUS, that were exclusively used with portable oxygen concentrators and that were designed for individuals with chronic breathing issues, met the requirements for secondary tariff classification under subheading 9817.00.96, HTSUS. The Protestant highlighted how just like in N311891, their product is also specially designed for use with a medical device that is intended to treat individuals who are physically and mentally handicapped, thus qualifying their product for secondary tariff classification in subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established 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. 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. The issue of what constitutes a “therapeutic” article under the Nairobi Protocol was addressed in Richards Medical Co. v. United States, 720 F. Supp. 998 (CIT 1989), aff'd, 910 F.2d 828 (Fed.Cir.1990), which held that “therapeutic” articles are those that are used to heal or cure the condition causing a handicap, as opposed to those articles which are designed to compensate for, or adapt to, the handicapped condition. In Sigvaris, 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, 3 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 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. (Sigvaris, supra). While you claim that the power supplies are in alignment with the definition of “specially designed” outlined in the Sigvaris, we are not convinced that they are. You have stated that the power supplies are “custom-made” to Nextern’s specifications, but through our review, we have come to the conclusion that the power supplies are not “easily” distinguishable from other power adapters for use with 120 Volt AC or 230 Volt AC outlets that are used by the general public. Additionally, we find that the Flexitouch Plus device that the power supplies are designed to be used for is a therapeutic article. As mentioned in Richard Medical, therapeutic articles are those that “…are used to heal or cure the condition causing a handicap, as opposed to those articles which are designed to compensate for, or adapt to, the handicapped condition.” As described in your submission and on your website, the Flexitouch Plus device is used for daily at-home treatment to decrease the swelling associated with lymphedema. Also, the compression garments used with the Flexitouch Plus device are used to “reduce the progression of lymphedema”. This allows us to believe that the Flexitouch Plus devices that the power supplies are designed for are therapeutic, rather than adaptive, as outlined by the decision in Richard Medical Co. HOLDING: Based upon the information submitted, the subject power supplies for the Flexitouch Plus device are not eligible for duty-free treatment under subheading 9817.00.96, HTSUS. Accordingly, you should DENY this Protest with respect to the special classification under subheading 9817.00.96, HTSUS. You are instructed to notify the protestant of this decision no later than 60 days from the date of this decision. Any reliquidation of the entry or entries in accordance 4 with the decision must be accomplished prior to this notification. Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings will make the decision available to CBP personnel and the public on the Customs Rulings Online Search System (CROSS) at https://rulings.cbp.gov/, or other methods of public distribution. Sincerely, For Yuliya A. Gulis, Director Commercial Trade and Facilitation Division