CLA-2 RR:CTF:VSP JH
Michael Springman
Thrive Orthopedic
387 Ridge Point Drive
Carmel, IN 46032
RE: Articles for the handicapped; Subheading 9817.00.96; Equinus Brace
Dear Mr. Springman:
This is in response to your letter dated June 6th, 2025 requesting reconsideration of New
York Ruling Letter (“NY”) N348800, dated June 6. 2025. In that ruling, the National
Commodity Specialist Division (“NCSD”) denied your request for duty-free treatment under
subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), for the
Equinus Brace (“Brace”).
The product at issue is described as a prescription-based, non-ambulatory L-shape,
length-adjustable brace. There are different versions of the Equinis Brace: the Equinus Brace
(SKU numbers IQ-1001 and IQ-1004), the Pediatric Equinus Brace (SKU number IQ-1002), and
the Equinus Brace (XL) (SKU number IQ-1003). The items are identical in shape, but vary in
size. Each features joint hinges in 10-degree increments, adjustable straps, a switch, and an
extension post. It is designed to treat Plantar Fasciitis and ankle joint contracture (also referred to
as Equinis Deformity). The brace is intended to be used when sitting, and it stretches specific
areas of the user’s calf muscle by keeping the knee straight while flexing the foot upwards. The
product is classified under 9021.10.00, HTSUS, which is not being disputed.
In NY N348800, U.S. Customs and Border Protection (CBP) held that, because the brace
was not specifically designed for use by the handicapped, it was not eligible for duty-free
treatment under subheading 9817.00.96, HTSUS. Thrive believes this decision was wrong for
the following reasons:
Thrive believes that despite the mention of the brace’s uses for multiple other
conditions, including plantar fasciitis, the brace qualifies under subheading
9817.00.96 because its core function and design are tailored for the management
of chronic ankle equinis, a progressive disabling condition.
Thrive believes that according to the decision from Sigvaris, Inc. v. United States,
227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir.
2018), even though there is mention of use of the brace for dancers and athletes,
incidental use by non-disabled individuals should not disqualify the brace from
treatment under subheading 9817.00.96, HTSUS.
Thrive reaffirms that ankle equinis is a chronic, systemic, and physically disabling
condition.
Thrives believes that the brace satisfies each of the five factors outlined in the
Sigvaris decision:
1. The brace has physical properties not found in consumer orthotics;
2. The brace is designed for contracture management in chronically
impaired populations and use by the general public is unlikely and
incidental;
3. Over 94 percent of sales are to licensed clinical providers and not
general or retail stores
4. The brace is not available through consumer marketplaces; and
5. The brace is registered as an FDA Class I medical device that requires
clinical oversight and is not designed for unsupervised consumer use.
Thrive believes that the brace should not be considered a diagnostic tool nor a
device intended for short-term therapeutic relief. Rather, its application is
restorative and mobility-preserving, aligning it with the intent and legal
representation of subheading 9817.00.96, HTSUS.
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.
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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, 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 reaffirm your claim that the brace is in alignment with the
definition of “specially designed” outlined in the Sigvaris, we agree with the NCSD that it is not.
You claim that ankle equinis is a progressive chronic, disabling condition, but research allows us
to believe that those with ankle equinis can recover from it with appropriate management
(stretching, exercise, physical therapy, etc.) in a few months; only, in select cases are more
severe treatments needed. See https://www.thefeetpeople.com.au/symptoms-we-treat/ankle-
equinus/; see also https://www.ncbi.nlm.nih.gov/books/NBK606130/. Our research also shows
that the population of people who develop equinis and plantar fasciitis are not always those who
suffer from long-standing disabilities, as they can also be caused for other reasons such as having
your foot in a cast, tight calf muscles, etc. See Id.
Additionally, you reject the claim that the brace is therapeutic or a diagnostic tool, and
state that it is not intended for short-term relief. 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.” On
your website you state that the brace’s goal is to “get long-lasting pain relief by addressing the
root cause…” Also, the description on your website says that the brace is for “simple effective
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relief”, and describes its use for “1-hour per day treatment”. This allows us to believe that the
brace in many instances is therapeutic as outlined by the decision in Richard Medical Co.
Further, you reference how the court in Sigvaris mentions that incidental use by non-
disabled does not automatically disqualify a good from subheading 9817.00.96, HTSUS,
treatment. You offer that the brace is not available commercially and needs clinical supervision,
to justify that use by the general public is unlikely and incidental. However, in addition to
mentioning use by non-disabled consumers (professional athletes and performers) on your
website, you also describe the brace to be the “… go-to non-surgical treatment for common foot
and ankle conditions.” Thus, we believe that the probability of use by the general public is
likely quite common.
CBP affirms the finding of N348800 that the Equinis brace is not eligible for duty free
treatment under subheading 9817.00.96, HTSUS.
Sincerely,
Monika R. Brenner, Chief
Valuation & Special Programs Branch
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