H352857

H352857 December 4, 2025 OT:RR:CTF:VS H352857 ME CATEGORY: Classification TARIFF NO.: 9817.00.96 Stefan Erickson, CEO Delta International Services and Logistics (USA) Inc, dba Erikson Strong Medical 31001 Edgewater Dr. Magnolia, TX 77354 RE: Articles for the Handicapped, Subheading 9817.00.96, HTSUS; Scrambler Therapy Dear Mr. Erickson: The following is our decision regarding your ruling request submitted on August 12, 2025, on behalf of Delta International Services and Logistics (USA) Inc, dba Erikson Strong Medical (“Erikson”) to U.S. Customs and Border Protection’s (CBP’s) National Commodity Specialist Division. The request was forwarded to the Valuation and Special Programs Branch on September 10, 2025, for a decision on the applicability of subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), to the Scrambler Therapy ST-5A device. FACTS: Erikson “is an agency created for the international development of Scrambler Therapy® Technology.” Erikson intends to import the Scrambler Therapy ST-5A device from Italy, which is a “5-channel electro-analgesia, neuromodulation medical device,” approved by the Federal Drug Administration (FDA). Erikson states that the principal use of the device is “for the management of severe, long-term, drug-resistant chronic pain in individuals suffering from debilitating conditions such as Complex Regional Pain Syndrome (CRPS), Chemotherapy- Induced Peripheral Neuropathy (CIPN), Post-Herpetic Neuralgia, and other forms of severe neuropathic pain that substantially limit major life activities.” 1 The Scrambler Therapy device consists of a 120v d 120V/220V power supply, digital display, a main control unit and five independent channels that connect to the patient via disposable surface electrodes. The device operates by “generating ‘artificial biopotentials’ that transmit synthetic ‘non-pain’ information through the patient's C-fiber nerve pathways,” thereby interrupting pain signals to the brain. Erikson claims that the device is operated by trained medical professionals whose “role is to strategically place and, if necessary, adjust disposable surface electrodes on the patient’s skin following defined treatment protocols.” Commercial documents provided by Erikson state that the “treatment protocol typically includes 10 consecutive sessions over two weeks, lasting about 45 minutes each,” with booster sessions provided as needed. Erikson argues that the device should be classified under subheading 9817.00.96, HTSUS, as a product “specifically designed or adapted” for “handicapped persons.” Erikson claims that the device is “exclusively used to treat ‘chronic, intractable pain,’ a condition that constitutes a chronic physical impairment which substantially limits one or more major life activities,” consistent with subheading 9817.00.96, HTSUS. Erikson also argues that the device has no “curative value for the disease that caused the pain, and can only be used for analgesic purposes.” Therefore, Erikson states that the Scrambler Therapy is an ”adaptive device that allows a handicapped person to function,” by temporarily relieving chronic pain. With the submission, Erikson provided several documents demonstrating what types of conditions the device is designed to treat. The Scrambler Therapy’s instruction manual states that it is indicated for three broad categories of pain: • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain. • Symptomatic relief of acute pain. • Symptomatic relief of post-operative pain The “setup guide” provided by the Erikson states that the Scrambler Therapy device is designed to specifically treat “chronic neuropathic pain.” The guide notes that “[a]lthough some studies suggest Scrambler Therapy® (ST) may have benefits for acute pain, patients with mechanical or acute pain are not currently considered ideal candidates-unless their condition is being managed solely for pain relief.” As an example, it states that someone diagnosed with “Diabetic Neuropathy Pain” would be an ideal candidate, whereas a person with “Bulging Disk Pain” would be a bad candidate. In an additional flier for the product, Erikson lists eight specific underlying conditions as “indications for use:” • Chemotherapy-induced Peripheral Neuropathy (CIPN) • Chronic Cancer Pain • Chronic Neuropathic Pain • Failed Back Surgery Syndrome (FBSS) • Sciatic and Lumbar Pain • Postherpetic Neuralgia (PHN) Brachial Plexus Neuropathy • Low Back Pain (LBP) • Chronic Neuropathic Pain Opioid Addiction 2 Furthermore, on Erikson’s public facing website, the device is advertised as a solution to “neurologic and/or oncologic chronic pain.” The website displays an additional list of 19 underlying conditions for which Scrambler Therapy may be effective in treating “…and many more:” • Diabetic Peripheral Neuropathy • Brachial Plexus Neuropathy • Non cancer pain such as neuropathic back pain • Sciatic and Lumbar Pain • Low Back Pain (LBP) • Endometriosis • Post-mastectomy Pain • Chemotherapy Induced Peripheral Neuropathy (CIPN) • Bone Metastases • Failed Back Surgery Syndrome (FBSS) • Chronic Neuropathic Pain Opioid Addiction • Chemotherapy Induced Peripheral Neuropathy (CIPN) • Pancreas and Abdominal Cancer Pain • Chronic Cancer Pain • Brachial Plexus Neuropathy • Complex Regional Pain Syndrome (CRPS) • Post-Herpetic Pain (Shingles pain) • Chronic Neuropathic Pain • Spinal Cord Stenosis Erikson also provided an article from the New England Journal of Medicine describing how the Scrambler Therapy device operates and its effectiveness. The article indicates that the Scrambler Therapy was “[d]esigned specifically for chronic neuropathic and cancer pain, especially opioid-resistant pain.” It further notes that “[b]eneficial effects have been reported to persist for weeks, months, or years after sessions.” ISSUE: Whether the Scrambler Therapy Model ST-5A device is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: Subheading 9817.00.96, HTSUS, came into effect in the United States through a series of international agreements and acts of Congress. Its basis is in the Agreement on the Importation of Educational, Scientific and Cultural Materials, opened for signature Nov. 22, 1950, 17 U.S.T. 1835, 131 U.N.T.S. 25, or Florence Agreement, drafted by the United Nations Educational, Scientific, and Cultural Organization (“UNESCO”) in July 1950. In 1976, UNESCO adopted the Nairobi Protocol to the Florence Agreement, which expanded the scope of products to include materials specially designed for handicapped persons. See Protocol to the Agreement on the 3 Importation of Educational, Scientific, or Cultural Materials, opened for signature 1 Mar. 1977, 1259 U.N.T.S. 3. Congress ratified the Nairobi Protocol and enacted it into U.S. law in 1983. Pub. L. 97-446, § 161, 96 Stat. 2329, 2346 (1983). Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. No. 100-418, 102 Stat. 1107) and Presidential Proclamation 5978 implemented the Nairobi Protocol by inserting permanent provisions such as subheading 9817.00.96 into the HTSUS. Subheading 9817.00.96, HTSUS, provides for: “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.” 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 states that subheading 98

Subheading 9817.00.96, HTSUS, came into effect in the United States through a series of international agreements and acts of Congress. Its basis is in the Agreement on the Importation of Educational, Scientific and Cultural Materials, opened for signature Nov. 22, 1950, 17 U.S.T. 1835, 131 U.N.T.S. 25, or Florence Agreement, drafted by the United Nations Educational, Scientific, and Cultural Organization (“UNESCO”) in July 1950. In 1976, UNESCO adopted the Nairobi Protocol to the Florence Agreement, which expanded the scope of products to include materials specially designed for handicapped persons. See Protocol to the Agreement on the 3 

Importation of Educational, Scientific, or Cultural Materials, opened for signature 1 Mar. 1977, 1259 U.N.T.S. 3. Congress ratified the Nairobi Protocol and enacted it into U.S. law in 1983. Pub. L. 97-446, § 161, 96 Stat. 2329, 2346 (1983). Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. No. 100-418, 102 Stat. 1107) and Presidential Proclamation 5978 implemented the Nairobi Protocol by inserting permanent provisions such as subheading 9817.00.96 into the HTSUS. Subheading 9817.00.96, HTSUS, provides for: “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.” 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 states that subheading 9817.00.96 excludes