H352973

H352973 June 23, 2026 OT:RR:CTF:VSP H352973 ACH CATEGORY: Classification TARIFF NO.: 9817.00.96 Jessica E. Lynd White & Case LLP 701 13th St. NW Washington, DC 20005 RE: Subheading 9817.00.96, HTSUS; Negative Pressure Wound Therapy Pump Dear Ms. Lynd: This is in response to your request, on behalf of Solventum Corporation (“Solventum”), dated August 20, 2025, for a binding ruling regarding the eligibility of Negative Pressure Wound Therapy Pumps (“NPWT Pumps”), namely the 3M™ ActiV.A.C.™ Therapy System, the 3M™ ActiV.A.C.™ Therapy System with iOn Progress™ Remote Therapy Monitoring, and the 3M™ V.A.C. Simplicity Therapy System, for subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), treatment. A meeting was held on April 15, 2026, and additional information was submitted April 23, 2026. Our ruling is set forth below. FACTS: NPWT Pumps are medical device systems with specially manufactured parts, including specialized canisters, tubes, foams, adhesive drapes, and SensaT.R.A.C. pads that deliver negative pressure to draw wound edges together, remove exudate and infectious materials, promote granulation tissue formation, prepare the wound bed for closure, and reduce edema. Solventum’s website states that “[t]he V.A.C. Therapy System is an integrated wound management system for use in acute and extended care settings… [the] System is designed for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure) flaps and grafts.”1 The listing for the 3M™ ActiV.A.C.™ Therapy Unit also states that “[it] is an integrated wound management system for use in acute, extended[,] and home care settings.”2 1 https://www.solventum.com/en-us/home/f/b5005265195/ 2 https://www.solventum.com/en-us/home/f/b5005265184/ 2 Solventum is the parent company of U.S. importers KCI Imports, Inc. and KCI USA, Inc. (“affiliates”). The affiliates will act as the importers of record of the Pumps. Solventum states that NPWT Systems have been effective at managing recurring wounds in patients with diabetes, COPD, end stage renal disease, quadriplegia, and paraplegia. Solventum also states that the NPWT Systems do not stop the recurrence of wounds or cure underlying disabilities and that the Pumps are portable and designed to be carried in a case. According to articles from the National Institutes of Health and other NPWT System producers, “[NPWT] is primarily utilized to treat complex wounds which are non-healing or at risk of non-healing, such as diabetic foot ulcers or skin grafts.”3 “NPWT can be used for the treatment of a variety of wound types if assessed to be appropriate. It can be used in chronic or acute wounds, as well as open or closed wounds. Some examples include: diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds, and dehisced wounds. Healthcare providers often treat chronic wounds that leave the wounds susceptible to infection.”4 “NPWT is often administered for weeks, but it could be used for months. The length of therapy is very individualized and is affected by the type and size of the wound and the patient’s overall health and nutritional status.”5 Solventum states that patients require a prescription for the NPWT Pumps and can only obtain them from a medical goods supplier, commonly referred to as a durable medical equipment provider, after meeting criteria demonstrating medical necessity. The Pumps at issue are equipped with a controller, sensors, and a user interface. Solventum states that the main differences between the NPWT Pumps are their weight, their battery life, which canister sizes they can connect to, and whether pressure can be delivered continuously or intermittently through the pumps. The Pumps are equipped with 3M™ SensaT.R.A.C. technology that delivers, monitors, and maintains pressure at the wound site. The Pumps also have safety features such as alarms and alerts to allow them to maintain optimal therapy settings. Open pore reticulated polyurethane foams or polyvinyl alcohol foams are cut to fit within wounds and then covered with adhesive drapes. A hole is cut into the adhesive drape, and a specialized SensaT.R.A.C. pad is placed over the wound. The open cells of the foam enable equal distribution of negative pressure (exerted by the NPWT Pumps) across the surface of the wound. The NPWT Pumps are connected to a canister which itself is connected to a tube that ultimately connects to the SensaT.R.A.C. pad. The foam, adhesive drape, and pads are typically sold together as part of a dressing kit, but can also be purchased separately. The canister used to collect fluids is sold separately from both the dressing kits and NPWT Pumps. Solventum states that there are differences between NPWT devices used temporarily after surgery and those used to treat wounds that develop as the result of a chronic disability. Currently, NPWT devices that are used to heal post-surgical wounds may be distinguished from the NPWT Pumps by the shape of the dressings used with the NPWT device and by whether the NPWT device is disposable. NPWT devices used for post-surgical wounds are used with rectangular strip dressings or certain pre-cut shape dressings that are placed over an incision, as 3 https://www.ncbi.nlm.nih.gov/books/NBK576388/ 4 https://pensarmedical.com/articles/negative-pressure-wound-therapy-complete-guide/ 5 https://pensarmedical.com/articles/negative-pressure-wound-therapy-complete-guide/ 3 compared to sterile foam dressings that are cut and customized to fit and fill the wounds healed by the NPWT Pumps. Additionally, NPWT devices that are used to heal post-surgical wounds tend to be single patient and disposable units that function for 7-14 days because such devices respond to the short-term need of surgical incisions as compared to long-term chronic wounds healed by the NPWT Pumps. When these post-surgical devices are used for chronic disabilities, patients will still use foam dressings that are fitted to the wound’s shape and size rather than strip dressings. Nonetheless, it is stated that NPWT devices will typically not be used in healthy individuals as opposed to individuals with underlying co-morbidities. In the meeting between CBP and Solventum’s representatives, Solventum provided insurance authorization diagnosis data showing that 89% of the NPWT Pumps at issue were purchased by those suffering from diabetes, quadriplegia/paraplegia, end stage renal disease, Peripheral Artery Disease (“PAD”), amputation, or Peripheral Vascular Disease (“PVD”). ISSUE: Whether the NPWT Pumps imported by Solventum are eligible for duty-free treatment under 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 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. 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, perf

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 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. 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). 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. Thus, eligibility within subheading 9817.00.96, HTSUS, depends on 
4 whether the article is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the e