OT:RR:CTF:VS H331366 TMF
Margaret R. Polino, Esq.
Neville Peterson LLP
17 State Street - 19th Floor
New York, NY 10004
RE: Revocation of HQ 563109 and HQ 563125; Modification of NY N011491, NY
I80189, NY N071646, NY N302256, NY N075840, NY N263755, NY N234669; Eligibility
of defibrillator cases, AC & DC power adapters, and chest compression systems for
duty-free treatment under subheading 9817.00.96, HTSUS; Nairobi Protocol; Articles
specially designed or adapted for the use or benefit of the blind or other physically or
mentally handicapped
Dear Ms. Polino:
This is in reference to Headquarters Ruling Letter (“HQ”) 563109, issued to you
on October 19, 2004, concerning the eligibility for duty-free treatment under subheading
9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), of imported
defibrillators and components. In HQ 563109, U.S. Customs and Border Protection
(“CBP”) determined certain external defibrillators and components were eligible for duty-
free treatment under subheading 9817.00.96, HTSUS. We have since reviewed HQ
563109 and determined it is incorrect. Similarly, we also reviewed the following eight
rulings, and find them to be in error: HQ 563125, dated December 27, 2004; New York
Ruling Letter (“NY”) N011491, dated June 19, 2007; NY I80189, dated April 15, 2002;
NY N071646, dated September 10, 2009; NY N302256, dated March 6, 2019; NY
N075840, dated September 25, 2009; NY N263755, dated May 1, 2015; and NY
N234669, dated November 19, 2012.
It is now CBP’s position that defibrillators and components are not eligible for
duty-free treatment under subheading 9817.00.96, HTSUS. For the reasons set forth
below, we hereby revoke HQ 563109 and HQ 563125, and modify NY N011491, NY
I80189, NY N071646, NY N075840, NY N234669, NY N263755, and NY N302256, as
to the eligibility under subheading 9817.00.96, HTSUS, as discussed below.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. § 1625(c)(1)), as
amended by section 623 of Title VI (Customs Modernization) of the North American
Free Trade Agreement Implementation Act, Pub. L. No. 103–182,107 Stat. 2057, 2186
(1993), notice of the proposed action was published on November 27, 2024, in Volume
58, Number 47 of the Customs Bulletin. No comments were received in response to
this notice.
FACTS:
The defibrillator cases (“cases”) in HQ 563109 are made in China and are made
of polyester fabric. The dimensions of the cases correspond to the shape of automated
external defibrillators they are designed to carry. One sample case has a special side
opening to access the battery. This case also features an inside pocket to store
electrodes and cables. The other sample has a velcro layer on the inside to secure the
defibrillator in place. The cases manufactured for Medtronic are sold only in conjunction
with its sale of defibrillators. NY N011491, NY I80189, NY N071646, and NY N302256,
involve various styles of carrying cases for automated external defibrillators (AEDs),
such as the Philips IntelliVue MP2/X2 patient monitor and Philips Heartstart Defibrillator
MRx/MRx ALS, with dimensions that correspond with the shape of the AEDs that are
designed to detect a subject’s heart rhythm, and if an irregular rhythm is detected, to
administer an electric shock to restore the heart to normal rhythm.
HQ 563125 concerns an AC and DC power adapter that also charges the battery
pack of the Physio-Control LIFEPAK 12 defibrillator/monitor series (“LIFEPAK 12”), an
advanced resuscitation portable device. NY N234669 concerns printed circuit board
assemblies (PCBAs) that contribute to the effective and unique functioning of advanced
portable resuscitation devices, specifically the LIFEPAK series defibrillators.
NY N075840, concerns the Lucas chest compression system with accessories,
such as a regulator, connector, stabilization strap, and extension hose, and carry bag.
NY N263755 concerns additional items that are sold separately with the system, such
as a battery charger, a corded auxiliary power supply unit, a unit charger for the car, a
back plate, and back plate grip tape. The sole purpose of the Lucas system is to
provide automated CPR so that the person can live long enough to obtain proper
medical treatment for what caused the arrhythmia in the first place. The system
mechanically compresses the chest/heart to cause oxygenated blood to move along the
circulatory system, most importantly to the brain.
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ISSUE:
Whether the subject articles are eligible for subheading 9817.00.96, HTSUS,
treatment.
LAW AND ANALYSIS:
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 the 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: “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.”
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.
CBP has previously held that a person suffering from arrythmia, or bradycardia is
physically handicapped as defined in U.S. Note 4(a) to Subchapter XVII. In
Headquarters Ruling Letter (“HQ”) 556243, dated December 2, 1991, and HQ 557302,
dated March 17, 1993, CBP held that internal defibrillator pacemakers are eligible for
duty-free treatment under subheading 9817.00.96, HTSUS. In HQ 556243, the article
under consideration was referred to as a pacer-cardioverter-defibrillator, and although
not specifically mentioned in the FACTS portion of HQ 556243, it is a device that is
implanted into the chest of the afflicted patient for long-term use. See
https://pubmed.ncbi.nlm.nih.gov/7743010/. After the issuance of these decisions, HQ
563109 granted a defibrillator case subheading 9817.00.96, HTSUS, treatment, under
the mistaken belief that the same type of defibrillators considered in HQ 556243 and HQ
557302 were involved.
Subsequently, although several of the rulings discussed in the FACTS above,
referred to U.S. Note 4(b) and the exclusion of subheading 9817.00.96, HTSUS, to
articles designed to treat an acute or transient disability, or to diagnostic articles, the
rulings relied on the finding in HQ 563109. For example, in NY N075840, although the
chest compression system was stated to be strapped around the chest of a victim in
order to allow steady compression to the chest for as long as necessary, and that the
“sole purpose of this system is to provide automated CPR so that the person can live
long enough to obtain proper medical treatment for what caused the arrhythmia in the
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first place”, relying on HQ 563109, subheading 9817.00.96, HTSUS, treatment was
granted. Similarly, in NY N011491, pertaining to defibrillator cases for the Phillips
Automated External Defibrillator, it was stated that this article is “an electronic device
designed to deliver an electric shock to a victim of sudden cardiac arrest” and that its
typical use is for storage, ready for use, in case someone suffers a sudden cardiac rest.
This type of use would be for acute purposes. In fact, in NY N071646, one of the
articles under consideration, the IntelliVue monitors, was denied subheading
9817.00.96, HTSUS, treatment, because there was nothing to show that the article was
specially designed to treat those with chronic impairments, as opposed to those with
temporary ailments. Rather, the device provided “the ability to have a dedicated
monitor for every patient that comes into the hospital, and the decision noted that most
patients admitted into a hospital do not suffer from a chronic impairment.
Therefore, after further examination and consistent with the statements made in
the ruling requests at issue, we find that, as opposed to internal
pacemakers/defibrillators, external defibrillators are primarily used to evaluate and treat
an acute or transient disability such as an acute cardiac event. Someone suffering from
an irregular heart rhythm or cardiac event, requiring the use of an external defibrillator
may go on and live a normal life thereafter. If indeed, further treatment is required
necessitating an internal pacemaker/defibrillator, such articles are already granted
subheading 9817.00.96, HTSUS, treatment per HQ 556243, and HQ 557302. As such,
it is our view that the prior decisions erroneously granted duty-free treatment to all
defibrillators and their components, as external defibrillators are designed for acute
situations, and they should be modified or revoked.
HOLDING:
The subject defibrillators and components are not eligible for subheading
9817.00.96, HTSUS, treatment.
EFFECT ON OTHER RULINGS:
HQ 563109 and HQ 563125 are REVOKED. NY N011491, NY I80189, NY
N071646, NY N075840, NY N234669, NY N263755, and NY N302256 are MODIFIED
as to the application of subheading 9817.00.96, HTSUS.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days
after its publication in the Customs Bulletin.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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