CLA-2-90:OT:RR:NC:N3 135
Michael Springman
Thrive Orthopedics LLC
387 Ridge Point Drive
Carmel, IN 46032
RE: The tariff classification of ankle-foot orthoses from China
Dear Mr. Springman:
In your letter dated April 14, 2025, you requested a tariff classification ruling.
The products under consideration are Thrive Ankle-Foot Orthoses (AFOs) identified below:
Item 1: F3 Anterior Carbon Fiber AFO / F3 Anterior FlexTrim Carbon Fiber AFO.
The two product names are two different versions of a similar design. The items are identical in shape
and size, but one version has more rigidity while the other version is more flexible to accommodate
different physical handicaps and gait needs. This item comes in five sizes, left and right. Each
individual product weighs between 0.3 and 1 lbs.
F3 Anterior Carbon Fiber AFO SKU numbers include: AXSLT, AXSRT, ASLT, ASRT, AMLT,
AMRT, ALLT, ALRT, AXLLT, and AXLRT.
F3 Anterior FlexTrim Carbon Fiber AFO SKU numbers include: FAXSLT, FAXSRT, FASLT,
FASRT, FAMLT, FAMRT, FALLT, FALRT, FAXLLT, and FAXLRT.
Item 2: F5 Spiral Carbon Fiber AFO / F5 Spiral FlexTrim Carbon Fiber AFO.
The two product names are two different versions of a similar design. The items are identical in shape
and size, but one version has more rigidity while the other version is more flexible to accommodate
different physical handicaps and gait needs. This item comes in five sizes, left and right. Each
individual product weighs between 0.3 and 1 lbs.
F5 Spiral Carbon Fiber AFO SKU numbers include: SXSLT, SXSRT, SSLT, SSRT, SMLT, SMRT,
SLLT, SLRT, SXLLT, and SXLRT.
F5 Spiral FlexTrim Carbon Fiber AFO SKU numbers include: FSXSLT, FSXSRT, FSSLT, FSSRT,
FMLT, FSMRT, FSLLT, FSLRT, FSXLLT, and FSXLRT.
Item 3: F5 Medial Carbon Fiber AFO.
The SKU numbers for this product are MXSLT, MXSRT, MSLT, MSRT, MMLT, MMRT, MLLT,
MLRT, MXLLT, and MXLRT. This item comes in five sizes, left and right. Each individual product
weighs between 0.3 and 1 lbs.
Item 4: F3 Hero Anterior Carbon Fiber AFO.
The SKU numbers for this product are PASLT, PASRT, PAMLT, PAMRT, PALLT, PALRT,
PAXLLT, and PAXLRT. This item comes in four sizes, left and right. Each individual product
weighs between 0.3 and 0.5 lbs.
Item 5: UFO 51 Universal Carbon Fiber AFO.
The SKU numbers for this product are UFOLT, and UFORT. This item comes in two sizes, left and
right. Each individual product weighs between 0.3 and 1 lbs.
Items 1, 2, 3, and 5 are carbon fiber, non-inflatable, extremity splints manufactured specifically to give
ambulatory support to physically handicapped individuals suffering from chronic disorders such as cerebral
palsy, Charcot-Marie-Tooth syndrome, chronic hemiparesis associated with stroke, multiple sclerosis, spinal
cord injury, and post-polio syndrome. Item 1 features an anterior shell design with a lateral strut and
full-length footplate, anatomically contoured to support the lower leg and foot in a manner that enables
normalized gait mechanics. Item 2 features a posterior, spiral design with a lateral strut and full-length
footplate, anatomically contoured to support the lower leg and foot in a manner that enables normalized gait
mechanics. Item 3 features a posterior shell design with a posterior lateral strut and full-length footplate,
anatomically contoured to support the lower leg and foot in a manner that enables normalized gait mechanics.
Item 5 features a height adjustable, posterior shell design with a lateral strut and full-length footplate,
anatomically contoured to support the lower leg and foot in a manner that enables normalized gait mechanics.
Item 4 is a carbon fiber, non-inflatable, extremity splint manufactured specifically to give ambulatory support
to physically handicapped pediatric patients suffering from chronic disorders such as footdrop, idiopathic toe
walker with no mid-foot collapse, gait deviations secondary to proprioceptive deficit, muscular dystrophy,
spastic diplegia. It features an anterior shell design with a lateral strut and full-length footplate, anatomically
contoured to support the tibia and foot in a manner that enables normalized gait mechanics.
All five items help reduce the risk of falls, improve gait efficiency, and minimize compensatory movements
that lead to further musculoskeletal complications. Each item is an integral part of the patient’s ambulation
and is used daily to enable safe and independent mobility.
You affirm that the Thrive Ankle-Foot Orthoses are specifically designed and intended for the ambulatory
support for individuals with chronic physical disabilities associated with lifelong degenerative neuromuscular
disorders such as cerebral palsy, Charcot-Marie-Tooth syndrome, chronic hemiparesis associated with stroke,
multiple sclerosis, spinal cord injury, and post-polio syndrome. They are not sold directly to consumers and
exclusively dispensed by medical professionals, fit by a certified orthotist, physician, and certified healthcare
professional, and require a prescription to accommodate patients with permanent physical handicaps to allow
them to walk.
The applicable subheading for the five Thrive Ankle-Foot Orthoses will be 9021.10.0090, HTSUS, which
provides for “[o]rthopedic appliances …: [o]rthopedic or fracture appliances, and parts and accessories
thereof: [o]ther.” The general rate of duty will be free.
Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and
Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings
9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate
of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition
to subheading 9021.10.0090, HTSUS, listed above.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise
must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. Products of China, including Hong Kong
and Macau, will be assessed an additional ad valorem rate of duty of 125 percent. Products from all other
countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must
report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.63, in addition to
subheading 9021.10.0090, HTSUS, listed above.
However, the additional duties imposed by subheadings 9903.01.24 or 9903.01.63 shall not apply to goods
for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to
applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry
under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings
9802.00.40, 9802.00.50, and 9802.00.60.
In your submission you requested consideration of a secondary classification under 9817.00.96, 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 9817.00.60, 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.
In 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), 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 U.S. Customs
and Border Protection (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.
Based on the information submitted, the Thrive Ankle-Foot Orthoses are specifically designed, marketed, and
intended for use exclusively by individuals with physical handicaps. They qualify for duty-free treatment
under subheading 9817.00.96, HTSUS.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division