CLA-2-90:OT:RR:NC:N3:135
Tan Albayrak
Reed Smith LLP
1 Blossom Yard,
London E16RS
United Kingdom
RE: The eligibility of EMG needle electrodes under the Nairobi Protocol treatment from Ireland
Dear Mr. Albayrak:
In your letter dated November 26, 2025, you requested a tariff classification ruling on behalf of your client,
Natus Medical Inc. Additional information was provided by email dated December 16 and December 17,
2025.
TECA® Elite Disposable Concentric Needle Electrodes and Dantec® DCN™ Disposable Concentric Needle
Electrodes are available in various styles. Each of these electrodes consists of a sharp, silicone coated
stainless-steel cannula with three-bevel tip design, a precisely centered tungsten core (insulated wire), a
polyesterimide insulator separating the cannula and core, a color-coded hub with a recording area direction
indicator, a hub cover, and a protective tube. These needle electrodes are connected to an electromyography
(EMG) device through a cable and designed for EMG examinations. They are intended for use with
recording, monitoring, and stimulation equipment for capturing biopotential signals, including
electromyographic and muscle potential signals.
TECA® MyoJect Disposable Luer Lock Needle Electrodes and Bo-ject® DHN Disposable Needle
Electrodes are available in different styles. Each comprises a stainless-steel hypodermic needle coated with
an insulator, a Luer lock or slip tip connector, a color-coded lead wire with a connector, and a protective tube.
These electrodes are designed for recording EMG activity while allowing injection of medication.
TECA® Elite Disposable Monopolar Needle Electrodes are offered in various styles. Each consists of a
coated stainless-steel needle and a color-coded hub. They are packaged with a reusable lead cable. They are
connected to an EMG device via the cable and designed for EMG examinations. They are intended for use
with recording, monitoring and stimulation equipment for capturing biopotential signals, including
electromyographic and muscle potential signals.
You state that the subject EMG needle electrodes are specially engineered for EMG and nerve conduction
studies procedures performed uniquely for the diagnosis, monitoring, and management of chronic
neuromuscular impairments. EMG and nerve condition studies are ordered specifically for individuals
suffering from long-term neuromuscular diseases, muscular dystrophy, peripheral neuropathies,
radiculopathies, motor neuron disease, and other permanent or chronic impairments affecting muscle
function. The general public has no conceivable use for EMG needles, which cannot perform injections, draw
fluids, or accomplish any general medical purpose. Their utility exists only within neurodiagnostic settings
and only when paired with EMG equipment and other specialized equipment. Natus, the manufacturer of
these needles, is internationally known for manufacturing diagnostic systems and consumables used
exclusively in neurodiagnostic, rehabilitative, and chronic impairment evaluation spaces. The company does
not manufacture general consumer medical products, and their portfolio is devoted to diagnostic testing and
neurological patient care. The needles discussed herein are sold directly to hospitals, and in most cases
Veterans Affairs-run hospitals. Each needle is individually packaged for single use, pre-sterilized, and
labeled exclusively for its purpose, with technical specification markers for appropriate handling by
professionals. The labeling and presentation communicate clearly that the merchandise is suitable only for
diagnosis of chronic neuromuscular disease and not for general medical use.
In your submission you requested consideration of a classification under 9817.00.96, HTSUS, which applies
to articles and parts 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: “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.” 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 9817.00.96, 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.
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.
Online research indicates that EMG and nerve conduction studies (NCS) are electrodiagnostic procedures
designed to measure the electrical activity of muscles and nerves. EMG measures the electrical
activity within muscles, both at rest and during contraction, using a needle electrode. NCS, on the other hand,
measures the speed and strength of electrical signals as they travel along nerves, typically utilizing a surface
electrode (which is not part of this ruling request). These tests are valuable tools for diagnosing health
conditions that may have damaged muscles or nerves, or impaired their coordinated function. While they can
be performed independently, EMG and NCS are commonly conducted together. The EMG needle electrodes
are specifically used in conjunction with EMG devices for these electrodiagnostic procedures. Consequently,
given that U.S. Note 4(b) to Subchapter XVII of Chapter 98 explicitly excludes diagnostic articles from
subheading 9817.00.96, HTSUS, the instant EMG needle electrodes are ineligible for duty-free treatment
under HTSUS 9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division