OT:RR:CTF:EMAIN H303312 DSR
Center Director
Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise
U.S. Customs and Border Protection
1100 Raymond Blvd.
Newark, NJ 07730
ATTN: Jessica C. Sutton, Senior Import Specialist, CEE – Pharmaceuticals, Health
and Chemicals
Re: Protest and Application for Further Review No. 2704-19-102404; Classification of
pulsed electromagnetic field therapy systems from Lichtenstein
Dear Center Director:
The following is our decision regarding the Application for Further Review of
Protest No. 2704-19-102404 filed on behalf of Bemer USA, LLC (“Protestant”).
Protestant contests the classification by U.S. Customs and Border Protection (“CBP”) of
two models of pulsed electromagnetic field (“PEMF”) therapy systems under the
Harmonized Tariff Schedule of the United States (“HTSUS”). Our decision as to the
proper tariff classification of the devices and to the disposition of the instant protest is
set forth below.
FACTS:
The subject items are identified as the Bemer Professional Set (Item 410200)
and the Bemer Classic Set (Item 410100). Bemer’s PEMF therapy systems are a family
of noninvasive devices designed use PEMF to stimulate muscles by improving local
blood distribution. The devices work by emitting an electromagnetic field of varying
intensity and frequency. The specific set components of the Professional Set are:
1. B.BOX Professional Control Unit;
2. B.BODY Pro Full Body application module;
3. B.SPOT selective treatment application module, which includes a fixing strap
& B.GRIP handle;
4. B.PAD small-scale treatment application module;
5. B.LIGHT light treatment application module for skin treatment;
6. Protective Goggles for use with the B.LIGHT;
7. B.SCAN signal tester module for function check;
8. A protective cover for the B.BODY application module to protect it from dirt
from a user’s shoes;
9. A wall mount for the B.BOX control unit;
10. A power supply for the B.BOX control unit; and,
11. A Car Power Cable for the B.BOX control unit.
The Classic Set is a smaller set consisting of the following elements:
1. B.BOX Classic Control Unit;
2. B.BODY Pro Full Body application module;
3. B.SPOT selective treatment application module, which includes a fixing strap
& B.GRIP handle;
4. B.SCAN signal tester module for function check; and,
5. A power supply for the B.BOX control unit.
CBP liquidated the items in subheading 8543.70.99, HTSUS, which provides for
“Electrical machines and apparatus, having individual functions, not specified or
included elsewhere in this chapter; parts thereof: Other machines and apparatus: Other:
Other: Other.” Protestant asserts that the items are classified in subheading 9018.90.75,
HTSUS, “Instruments and appliances used in medical, surgical, dental or veterinary
sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-
testing instruments; parts and accessories thereof: Other instruments and appliances
and parts and accessories thereof: Optical instruments and appliances and parts and
accessories thereof: Other: Electro-medical instruments and appliances and parts and
accessories thereof: Other: Other.”
ISSUE:
What is the proper classification under the HTSUS of the subject products?
LAW AND ANALYSIS:
Initially, we note that the matter is protestable under 19 U.S.C. §1514(a)(2) as a
decision on classification. The protest was timely filed within 180 days of liquidation of
the first entry. See Miscellaneous Trade and Technical Corrections Act of 2004, Pub.L.
108-429, §2103(2)(B) (ii), (iii), codified as amended at 19 U.S.C. §1514(c)(3)(2006).
Further Review of Protest No. 2704-19-102404 is properly accorded to Protestant
pursuant to 19 C.F.R. 174.24(a) because the decision against which the protest was
filed is alleged to contradict prior rulings issued by CBP.
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Classification under the HTSUS is determined in accordance with the General
Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods shall be
determined according to the terms of the headings of the tariff schedule and any relative
section or chapter notes. In the event that the goods cannot be classified solely on the
basis of GRI 1, and if the headings and legal notes do not otherwise require, the
remaining GRIs 2 through 6 may then be applied in order.
The HTSUS provisions under consideration are as follows:
8543 Electrical machines and apparatus, having individual functions, not
specified or included elsewhere in this chapter; parts thereof:
* * *
9018 Instruments and appliances used in medical, surgical, dental or veterinary
sciences, including scintigraphic apparatus, other electro-medical
apparatus and sight-testing instruments; parts and accessories thereof:
The Harmonized Commodity Description and Coding System Explanatory Notes
(“ENs”) constitute the official interpretation of the Harmonized System at the
international level. While neither legally binding nor dispositive, the ENs provide a
commentary on the scope of each heading of the HTSUS and are generally indicative of
the proper interpretation of the headings. It is CBP’s practice to consult, whenever
possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89–80, 54 Fed.
Reg. 35127, 35128 (August 23, 1989).
Section XVI, HTSUS, contains Chapter 85, HTSUS, and Note 1(m) to Section
XVI states that Section XVI does not cover articles of Chapter 90. Further, EN 85.43
states the following:
This heading covers all electrical appliances and apparatus, not falling in
any other heading of this Chapter, nor covered more specifically by a
heading of any other Chapter of the Nomenclature, nor excluded by the
operation of a Legal Note to Section XVI or to this Chapter. The principal
electrical goods covered more specifically by other Chapters are electrical
machinery of Chapter 84 and certain instruments and apparatus of Chapter
90.
Protestant asserts that the items are classified in subheading 9018.90.75,
HTSUS, which provides for, in pertinent part, other electro-medical instruments and
appliances and parts and accessories thereof. EN 90.18 states the following:
This heading covers a very wide range of instruments and appliances
which, in the vast majority of cases, are used only in professional practice
(e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either
to make a diagnosis, to prevent or treat an illness or to operate, etc.
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Therefore, our analysis begins with whether the subject items are covered by
heading 9018, HTSUS. Protestant cites to NY I85148 (September 2, 2002) and NY
I86679 (October 15, 2002) to support its assertion that the subject devices are devices
of heading 9018, HTSUS, i.e., instruments used in medical practice. In NY I85148, the
devices were described in the following manner:
An Alphatron 4100 signal generator, which generates electrical impulses for
use in PEMF (Pulse Electromagnetic Field) therapy. This device is
specifically designed by Alphatron, the German manufacturer, to emit low-
frequency energy for PEMF therapy.
An MF 550 mm air coil/bed unit. The air coil is fitted with special brackets
so that it can be mounted and slide on the bed rails. In addition, the bed is
specially designed for use with the air coil, in that the bed is configured with
rails to allow the air coil to slide up and down the length of the bed. Thus,
the air coil and specially designed bed are designed to be used as a unit.
The air coil itself consists of 14-gauge copper wire, which is wound on a
plastic spool, and thereafter encased in plastic. The term ‘air coil’ in the
invoice description refers to the hollow section into which the patient’s body
(arm, leg, etc.) is placed for treatment. The function of the coil is to
transform the electrical energy provided by the signal generator into
magnetic energy so that it can be used for treatment on the affected area
of the patient.
In NY I86679, the four items under consideration are described as the following:
Alphatron 315 mm air coil: This coil is manufactured by Alpha Electronics in
Germany and is used in connection with “pulse electromagnetic field”
(PEMF) therapy. Because it is specially designed and built with PEMF in
mind, this coil is not a general purpose, off-the-shelf coil. The coil receives
electromagnetic pulses from a specially designed PEMF signal generator.
The function of the coil is to transform the electrical energy provided by the
signal generator into magnetic energy so that it can be used for treatment
on the affected area of the patient. Because of its smaller size, this coil is
specifically utilized for treatment of the extremities (feet or hands). In
operation, a patient will place his or her hands or feet inside the coil to
receive the PEMF therapy.
Alphatron MF 500 mm air coil: This coil is imported separately (without a
bed) and is also intended to be used for PEMF therapy. The function of this
coil is the same as the 315 mm coil, except that the MF 500 mm air coil is
larger than that of the 315 mm air coil. Thus, it is sufficiently large enough
for a normal person (the torso) to fit inside this air coil. The 500 mm air coil
is fitted with special brackets so that it can be mounted and slide on a
specially made bed (imported separately) for use in PEMF therapy.
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A flat applicator with two wall arms: This is essentially an air coil, serves the
same purpose as the 315 mm and 500 mm air coils, but is constructed
differently. The flat applicator is used for obese patients who are unable to
fit inside a 50 mm or 550 mm air coil. With the flat applicator, one arm is
placed on one side (such as the chest) of the patient, and the other arm is
placed on the other side of the patient (such as the back).
550 mm air coil with wall arm: This consists of a 550 mm air coil with a
mechanism that allows the air coil to be mounted on and maneuvered from
a wall. This mechanism permits the 550 mm air coil to be used without being
mounted on the specially designed PEMF bed, which can be rather
expensive. With the wall arm mechanism attached, the 550 mm air coil can
be used with any hospital or therapy bed.
In finding that the products in both cases were classified in heading 9018,
HTSUS, as other therapeutic electro-medical instruments and appliances, CBP noted
that although the size and cost of the devices would make individual home use the
exception, “the only uses indicated for the device are traditional goals of the medical
sciences, i.e., speeding healing and reducing pain.” See also NY N103875 (May 14,
2010); NY N103835 (May 14, 2010). 1
We also draw attention to HQ 082973 (Oct. 4, 1989), where CBP has recognized
that “intrinsically medical” devices may be classified in heading 9018, HTSUS, even
when they are used by patients instead of medical professional practice. Citing to EN
90.18, CBP stated:
Although the instruments in question are designed for laymen, not medical
professionals, their function is the same as the other apparatus mentioned in
Explanatory Note 90.18 -- to monitor the physical health of the patient .
In the opinion of this office, the fact that the patient is also the user of these
machines does not exclude these devices from heading 9018, HTSUSA. The
purpose for utilizing these instruments is intrinsically medical. These Digital Blood
Pressure Meters are electro-medical apparatus within heading 9018, HTSUSA,
even though they are not within that vast majority of instruments which are used
only in professional practice.
Here, the subject devices are used to provide non-invasive, painless treatment
for various conditions and ailments, as well as to enhance cardiac function, physical
1 Although the holdings in NY N103875 and NY N103835 are correct, they misstate EN 90.18 in stating
that the EN recognizes that such instruments are “only” used in hospitals or clinics. To the contrary, EN
90.18 merely recognizes that those types of instruments, “… in the vast majority of cases, are used only
in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to
make a diagnosis, to prevent or treat an illness or to operate, etc.” Of course, this means that there may
be cases where such instruments are used by persons other than doctors, surgeons, dentists, etc., and in
“non-professional practice” because the text of heading 9018, HTSUS, indicates only that such
instruments be used in medical, surgical, dental or veterinary sciences.
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fitness and endurance, body strength, energy level, stress reduction and the
enhancement of quality of life. This is purportedly achieved by the devices emitting
electromagnetic fields of varying intensities and frequencies that are meant to improve
local blood distribution, which would in turn in turn stimulate muscle growth and
wellness. The devices may be utilized by physicians or laymen.
Also, according to the 501(k) premarket notification submitted by Protestant, the
devices are designed for patient-managed self-use in home settings and are suitable for
“over-the-counter” use. The Professional Set is described on Protestant’s website as
being “aimed at [Protestant’s] professional customer and the most discerning of …
home users.” See https://united-states.bemergroup.com/en-US/product_sets/pro-set
(last visited March 19, 2020). 2 The Classic set is described as being aimed at “home
users who do not necessarily require the full range of applications.” See https://united-
states.bemergroup.com/en-US/product_sets/classic-set (last visited March 19, 2020). It
is unclear what is meant by the term “professional customer,” but the website
encourages users of the Professional Set to test the device at home, and the
aforementioned 501(k) premarket notification describes the therapy systems as
“substantially equivalent to other legally marketed over-the-counter devices within
physical medicine classifications NGX (Powered Muscle stimulator) … All are designed
for patient-managed self-use in a home setting.”
Regardless of the settings in which they are used, the Bemer sets are used to
provide non-invasive, painless treatment for various conditions and ailments, much like
the devices used for the “traditional goals of the medical sciences” in NY I85148 and NY
I86679, supra. Given the analysis of the Bemer Professional Set and the Bemer
Classic Set devices’ capabilities, we find that they are used as devices that are within
the scope of subheading 9018, HTSUS, and are of the class or kind of goods classified
in heading 9018, HTSUS.
As to the scope of heading 8543, HTSUS, we note that the heading provides for,
in part, “Electrical machines and apparatus, having individual functions, not specified or
included elsewhere in this chapter; Other machines and apparatus; … Other.”
[emphasis added]. Heading 8453 is a basket provision, and the Court of International
Trade has held that “classification of imported merchandise in a basket provision is
appropriate only when there is no tariff category that covers the merchandise more
specifically.” Apex Universal, Inc. v. United States, 22 C.I.T. 465 (1998). We have
already determined that the subject devices are within the scope of Chapter 90,
HTSUS, supra, and are thus specifically provided for elsewhere in the tariff other than
heading 8543, HTSUS.
2 The website also states that the Bemer Professional Set is imported with accessories that allows a user
to use the device “more comfortably in any situation …,” for instance, in a car via a car plug attachment.
The classifications of the included accessories are not at issue in this protest, as the sets’ control units
provide the essential character of the sets as imported.
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HOLDING:
By application of GRIs 1 and 6, the subject Bemer Professional Set and the
Bemer Classic set are classified under heading 9018, HTSUS, specifically under
subheading 9018.90.75, HTSUS, which provides for “Instruments and appliances used
in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus,
other electro-medical apparatus and sight-testing instruments; parts and accessories
thereof: Other instruments and appliances and parts and accessories thereof: Other:
Electro-medical instruments and appliances and parts and accessories thereof: Other:”
The 2019 column one, general rate of duty is “Free.”
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 on the
internet at www.usitc.gov/tata/hts/.
You are instructed to GRANT the protest.
You are instructed to notify the protestant of this decision no later than 60 days
from the date of this decision. Any reliquidation of the entry or entries in accordance
with the decision must be accomplished prior to this notification. Sixty days from the
date of the decision, the Office of Trade, Regulations and Rulings will make the decision
available to CBP personnel and the public on the Customs Rulings Online Search
System (CROSS) at https://rulings.cbp.gov/, or other methods of public distribution.
Sincerely,
for Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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