CLA-2-85:OT:RR:NC:N2:209
Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Ave., 24th Floor
New York, NY 10022
RE: The tariff classification of a wireless hub from Lithuania
Dear Ms. Abraham:
In your letter dated May 7, 2026, you requested a tariff classification ruling on behalf of your client, KORE
Wireless, Inc.
The item concerned is referred to as a KORE Wireless OmniHub, model CG100. This wireless transmission
hub is specifically for use with Philips Respironics’ ventilators (e.g., Trilogy EVO and EV300 ventilators).
The Philips Respironics’ ventilators provide noninvasive (NIV) and invasive (IV) positive pressure
ventilation to adult, pediatric, and infant patients, who suffer with profound chronic respiratory insufficiency
and chronic respiratory failure. The Philips Respironics ventilators are used solely by individuals with
chronic breathing problems.
The OmniHub cannot be used with other products due to its design. It is specifically designed and adapted for
use with the Philips Respironics’ ventilators (e.g., Trilogy EV300 and EVO ventilators). You state that the
OmniHub is an important accessory for these ventilators and is not used for any purpose by the general
public.
The KORE Wireless OmniHub CG100 is a cellular communications gateway with integrated Bluetooth
Classic & BLE. It is intended for connected healthcare applications (RPM and chronic care monitoring). It is
used in a patient’s homes to wirelessly connect to installed Philips ventilators. It securely reads telemetry
information from the ventilator on a periodic basis and securely forwards that information to the Philips
healthcare system (Care Orchestrator). The network connection between the OmniHub and Philips ventilators
is Bluetooth, and the network connection between the OmniHub and Philips healthcare systems is via
LTE/cellular networks.
The applicable subheading for the KORE Wireless OmniHub, model CG100, will be 8517.62.0090,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Telephone sets, including
smartphones and other telephones for cellular networks or for other wireless networks; other apparatus for the
transmission or reception of voice, images or other data, including apparatus for communication in a wired or
wireless network (such as a local or wide area network)…: Other apparatus for transmission or reception of
voice, images or other data, including apparatus for communication in a wired or wireless network (such as a
local or wide area network): Machines for the reception, conversion and transmission or regeneration of
voice, images or other data, including switching and routing apparatus: Other.” The general rate of duty will
be Free.
In your submission you requested consideration of a secondary 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.
Based on the information supplied, the KORE Wireless OmniHub, model CG100 does satisfy the 5 factors
set out by CBP. The device is used exclusively with Philips Respironics’ ventilators and cannot be adapted
for use with other devices. As a result, it is the opinion of this office that a secondary classification will apply
in subheading 9817.00.96, HTSUS.
The 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/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at
https://www.cbp.gov/trade/programs-administration/trade-remedies.
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 Steven Pollichino at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division