CLA-2-90:OT:RR:NC:N3 135
Jane Dempsey
Polsinelli PC
1401 I ("Eye") Street NW, Suite 800
Washington, DC 20005
RE: The tariff classification of a mechanical insufflation-exsufflation device from the United Kingdom
Dear Ms. Dempsey:
In your letter dated June 5, 2025, you requested a tariff classification ruling on behalf of Breas Medical, Inc.
You state the company is a well-known medical equipment producer of respiratory care devices designed for
those with chronic conditions.
Clearo MI-E (Mechanical Insufflation-Exsufflation) device is a portable airway clearance device that
provides cough modes and therapeutic modes. The cough modes include a manual mode, a basic auto mode,
a program auto mode, and a TreatRepeat mode. The therapeutic modes include an Intermittent Positive
Pressure Breathing (IPPB, noncontinuous ventilator) mode, and a non-invasive ventilation mode. The device
can also be used for oxygen therapy with IPPB.
The device is intended for adult or pediatric patients that have compromised secretion clearance and/or a
reduced ability to cough effectively. Individuals who may benefit from the use of the Clearo MI-E device
include any patient with an ineffective cough due to muscular dystrophy, amyotrophic lateral sclerosis (ALS)
or motor neuron disease (MND), myasthenia gravis, poliomyelitis, other neurologic disorders, and spinal
cord injury. The Clearo MI-E device can be used for IPPB and therefore may also be used in patients with
bronchopulmonary disease to promote effective secretion removal and or lung volume recruitment.
When used as a mechanical insufflator-exsufflator, it provides a positive pressure to the airway (insufflation),
followed rapidly by a negative pressure (exsufflation) to promote the removal of secretions. This is achieved
through increasing the expiratory flow from the lungs, in order to replicate normal cough function. Optional
oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition
to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the
clearance of respiratory secretions. The device achieves its intended use through a blower, which compresses
air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control
and monitor the operation. It is powered from either a main source or an internal battery.
The device offers MI-E for both invasively and non-invasively ventilated patients as well as patients who
breathe independently. It may be used either with a facemask, mouthpiece, or with a suitable adapter to a
patient’s endotracheal or tracheostomy tube (MI-E only). It must only be used non-invasively when using the
IPPB mode. Only a facemask or mouthpiece should be used to administer IPPB therapy with the device.
The device is intended for use within a hospital, institutional environment, or in the home. It must be
prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider.
You state that your client plans to sell this device directly to durable medical equipment suppliers, hospitals
(more specifically, their medical equipment at home stores/divisions), medical facilities, and through
specialized distributors.
The applicable subheading for the Clearo MI-E device will be 9019.20.0000, Harmonized Tariff Schedule of
the United States (HTSUS), which provides for “[o]zone therapy, oxygen therapy, aerosol therapy, artificial
respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The general rate of duty
will be free.
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. At this time products from all 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. 9903.01.25, in addition to subheading
9019.20.0000, HTSUS, listed above.
However, the additional duties imposed by subheading 9903.01.25 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 9817.00.96, 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 provided, the Clearo MI-E device does satisfy the five factors set out by CBP. As a
result, it is the opinion of this office that a secondary classification will apply in subheading 9817.00.96,
HTSUS. This decision is supported by previous NY ruling N316036, dated December 11, 2020. In the ruling,
CBP ruled that the carrying cases specially designed for the cough assist devices, which work similarly to the
instant device, qualified for duty-free treatment under subheading 9817.00.96.
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)
James Forkan
Acting Director
National Commodity Specialist Division