OT:RR:CTF:VSP H352973 ACH
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/
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/
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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, 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
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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 enumerated
exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
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. While the HTSUS does not establish a clear definition of substantial
limitation, in Sigvaris, 227 F. Supp. 3d at 1335, the CIT explained that “[t]he inclusion of the
word ‘substantially’ denotes that the limitation must be ‘considerable in amount’ or ‘to a large
degree.’”
We must first evaluate “for whose, if anyone’s, use and benefit is the subject article
specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris,
899 F.3d at 1314. In other words, we must consider whether such persons are suffering from a
permanent or chronic physical or mental impairment which substantially limits one or more
major life activities. Depending on the nature of the wound, a person whose wound requires
NPWT could be physically handicapped. In this case, it has been shown that the NPWT pumps
are primarily used for persons suffering from chronic wounds, including diabetic and
neuropathic ulcers. CBP has consistently held that persons with diabetes are considered
physically handicapped persons under U.S. Note 4(a) because they are limited in their ability to
perform a broad range of jobs because they must be able to monitor their blood sugar, inject
insulin if prescribed, and have work restrictions due to excessive urination, possible nausea,
dizziness and fainting. Therefore, persons with diabetes suffer from a permanent or chronic
physical impairment which substantially limits a major life activity and are considered physically
handicapped persons under U.S. Note 4(a). See Headquarters Ruling Letter (“HQ”) 561020,
dated October 14, 1998.
The Court of Appeals for the Federal Circuit (“CAFC”) clarified 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. This definition of ‘specially designed’ is
consistent with factors that Customs uses in discerning for whose use and benefit a product is
‘specially designed’ ... we adopt them in our analysis ....” Id. at 1314–15. In Danze, Inc. v.
United States, 319 F. Supp. 3d 1312, 1326 (CIT 2018), the CIT held that ADA compliance alone
was insufficient to show that an item was “specifically designed or adapted” for the handicapped
under subheading 9817.00.96, HTSUS.
Thus, to determine whether the NPWT Pumps are “specially designed” for the use or
benefit of a class of persons to an extent greater than for others, we must examine the following
five factors used by CBP and adopted by the CAFC in Sigvaris, 899 F.3d at 1314–15: (1)
physical properties of the article itself (e.g., whether the article is easily distinguishable in
design, form and use from articles useful to non-handicapped persons); (2) presence of any
characteristics 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) importation by manufacturers
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or distributors recognized or proven to be involved in this class or kind of articles for the
handicapped; (4) sale in specialty stores that serve handicapped individuals; and (5) indication at
the time of importation that the article is for the handicapped. See also T.D. 92–77 (26 Cust.
Bul. 240 (1992)).
The first two factors to consider in determining whether an article is “specially designed”
are the physical properties of the article and any characteristics of the article that easily
distinguish it from articles useful to the general public. In this case, the NPWT Pump is
designed for persons who have chronic wounds and are designed for continuous home use.
Evidence has also been submitted to distinguish the particular NPWT Pumps from those that are
used temporarily at the hospital.
The third and fourth factors to consider in determining whether an article is “specially
designed” are whether it is imported by manufacturers or distributors recognized to be involved
in this class or kind of articles for the handicapped and whether it is sold in specialty stores that
serve handicapped individuals. In this case, Solventum has provided evidence to show that the
NPWT Pumps are only available with a prescription directly from a medical goods supplier.
The fifth and final factor to consider is whether at the time of importation the article is for
the handicapped. At the time of importation, the NPWT Pump is imported by KCI Imports, Inc.
and KCI USA, Inc., affiliates of Solventum, and it is ready for use in treating chronic wounds.
With respect to whether the NPWT Pump is excluded because it is an article for an acute
or transient disability, or a therapeutic article, we refer to Richards Medical Co. v. United States,
13 CIT 519 (1989), which held that certain hip prosthetic articles were not therapeutic because
they did not heal the handicapped person nor cure the disease which caused the handicap. In HQ
556532, dated June 18, 1992, U.S. Customs held that canes were predominantly used by
permanently or chronically handicapped individuals, even though individuals with acute
disabilities such as sprained ankles could use them. On the other hand, Customs stated that
crutches were predominantly used by individuals with acute or transient disabilities, even though
they may be used by individuals with chronic or permanent disabilities.
In this case, we find that the NPWT Pumps are predominantly used by those with
permanent or chronic disabilities. Solventum provided evidence that the NPWT Pumps differ
from those used for temporary and acute wounds due to surgery and that a large majority of
those using the pumps at issue have chronic disabilities. Further, based on the evidence, we find
that, even if the wounds treated by the NPWT Pumps are acute, the wounds would have
developed due to underlying, chronic disabilities like diabetes. The NPWT Pumps are
prescribed to alleviate wounds caused by conditions such as diabetes, but they may not entirely
heal the wounds. The NPWT Pumps are similar to the prosthetics in Richards, supra, as it is an
article that allows the user to cope with the diabetic wound, but it does not cure the underlying
condition. See also Travenol Lab. v. United States, 17 CIT 69 (1993), in which the court
determined that kidney dialysis was not therapeutic because it did not restore the kidney function
of a person with renal failure. Therefore, we find that the NPWT Pumps at issue are eligible for
duty-free treatment under subheading 9817.00.96, HTSUS.
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HOLDING:
Based on the facts provided, the NPWT Pumps at issue are eligible for duty-free
treatment under subheading 9817.00.96, HTSUS, as articles specially designed or adapted for the
use or benefit of the blind or other physically or mentally handicapped persons.
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 the internet at
https://hts.usitc.gov.
Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the
assumption that all of the information furnished in connection with the ruling request and
incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
complete in every material respect. The application of a ruling letter by a Customs Service field
office to the transaction to which it is purported to relate is subject to the verification of the facts
incorporated in the ruling letter, a comparison of the transaction described therein to the actual
transaction, and the satisfaction of any conditions on which the ruling was based.”
A copy of this ruling letter should be attached to the entry documents filed at the time the
goods are entered. If the documents have been filed without a copy, this ruling should be
brought to the attention of the CBP officer handling the transaction.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
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