The eligibility for duty-free treatment under subheading 9817.00.96, HTSUS, of TCC-EZ® Total Contact Cast System from an unidentified country

N347220 April 9, 2025 CLA-2-90:OT:RR:NC:N3135 CATEGORY: Classification Shivali Puri Integra LifeSciences Sales LLC 1100 Campus Road Princeton, NJ 08540 RE: The eligibility for duty-free treatment under subheading 9817.00.96, HTSUS, of TCC-EZ® Total Contact Cast System from an unidentified country Dear Ms. Puri: In your letter dated March 31, 2025, you requested a tariff classification ruling on the TCC-EZ® Total Contact Cast System. TCC-EZ® Total Contact Cast System is said to be a specialized offloading device (a synthetic mesh cast supported by a cast boot) designed to provide a protective wound healing environment for diabetic foot ulcers (DFUs). It consists primarily of a stockinette, a felt padding, a white protective sleeve, a cast sock, and a customized cast boot. The system offloads the wound, reducing pressure and shear force, promoting healing, and protecting the affected limb from further trauma. A Total Contact Cast (TCC) is a cast used to help promote healing by minimizing pressure and shear force at the wound site. TCCs are used to treat patients suffering from diabetic foot ulcers (non-infected neuropathic foot ulcers), charcot neuroarthropathy, or for post operative surgical site protection. According to the submitted documents, the TCCs have demonstrated a wound healing (wound closure) rate of 88 percent of DFUs in 43 days and is recognized as the Gold Standard treatment for healing DFUs. The TCC-EZ® decreases the time of cast application compared to standard TCCs and makes applying and wearing a TCC easier. In your submission you requested consideration of a classification under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“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 9817.00.96, 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. U.S. Customs and Border Protection (“CBP”) and the courts have held that therapeutic articles within the context of this provision are those articles that heal or cure a condition. See T.D. 92-77, 26 Cust. B. & Dec. 240, 241 (1992); Travenol Laboratories, Inc. v. U.S., 17 CIT 69, (1993). Also, the courts and CBP have consistently held that therapeutic articles are articles whose purpose is the “complete or partial elimination of disease.” See Headquarters Ruling Letter (“HQ”) H285358, dated August 6, 2018. You state that “Diabetic foot ulcers ... are often a result of peripheral neuropathy, a condition that significantly impairs mobility and is considered a disability. DFU poses a substantial risk of amputation due to open wounds and potential infections.” The article you provided from Today’s Wound Clinic states that “Ulcer healing requires adequate blood supply, control of infection, appropriate wound care, debridement and off-loading. Off-loading has been proven to interrupt the pathogenesis of ulcer development and maintenance as well as lead to positive histologic wound changes.” “The TCC is effective in treating diabetic foot ulcers due to redistribution of plantar pressure over a large surface area, decreased shear stress, reductio of edema, enforced compliance and protection.” “TCCs have been listed by numerous sources as the gold standard for the treatment of diabetic neuropathic foot ulcerations.” “Evidence-based medicine demonstrates that the TCC is the best treatment modality to off-load diabetic foot ulcerations.” You also explain that the wound healing rate is at 88 percent with TCC treatment in 43 days, and that “TCC-EZ® maintains the therapeutic benefits of traditional total contact casting while addressing application challenges, resulting in a more efficient and user-friendly solution. In light of the above, the TCC-EZ® Total Contact Cast System is considered a therapeutic article, since it is effective in treating diabetic foot ulcers and recommended as a gold standard treatment for healing DFUs and preventing amputations. As such, it will be precluded from subheading 9817.00.96, HTSUS, per U.S. Note 4(b), subchapter XVII, Chapter 98. 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 fei.chen@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division