OT:RR:CTF:VS H352857 ME
Stefan Erickson, CEO
Delta International Services and Logistics (USA) Inc,
dba Erikson Strong Medical
31001 Edgewater Dr.
Magnolia, TX 77354
RE: Articles for the Handicapped, Subheading 9817.00.96, HTSUS; Scrambler Therapy
Dear Mr. Erickson:
The following is our decision regarding your ruling request submitted on August 12,
2025, on behalf of Delta International Services and Logistics (USA) Inc, dba Erikson Strong
Medical (“Erikson”) to U.S. Customs and Border Protection’s (CBP’s) National Commodity
Specialist Division. The request was forwarded to the Valuation and Special Programs Branch on
September 10, 2025, for a decision on the applicability of subheading 9817.00.96, Harmonized
Tariff Schedule of the United States (“HTSUS”), to the Scrambler Therapy ST-5A device.
FACTS:
Erikson “is an agency created for the international development of Scrambler Therapy®
Technology.” Erikson intends to import the Scrambler Therapy ST-5A device from Italy, which
is a “5-channel electro-analgesia, neuromodulation medical device,” approved by the Federal
Drug Administration (FDA). Erikson states that the principal use of the device is “for the
management of severe, long-term, drug-resistant chronic pain in individuals suffering from
debilitating conditions such as Complex Regional Pain Syndrome (CRPS), Chemotherapy-
Induced Peripheral Neuropathy (CIPN), Post-Herpetic Neuralgia, and other forms of severe
neuropathic pain that substantially limit major life activities.”
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The Scrambler Therapy device consists of a 120v d 120V/220V power supply, digital
display, a main control unit and five independent channels that connect to the patient via
disposable surface electrodes. The device operates by “generating ‘artificial biopotentials’ that
transmit synthetic ‘non-pain’ information through the patient's C-fiber nerve pathways,” thereby
interrupting pain signals to the brain. Erikson claims that the device is operated by trained
medical professionals whose “role is to strategically place and, if necessary, adjust disposable
surface electrodes on the patient’s skin following defined treatment protocols.” Commercial
documents provided by Erikson state that the “treatment protocol typically includes 10
consecutive sessions over two weeks, lasting about 45 minutes each,” with booster sessions
provided as needed.
Erikson argues that the device should be classified under subheading 9817.00.96,
HTSUS, as a product “specifically designed or adapted” for “handicapped persons.” Erikson
claims that the device is “exclusively used to treat ‘chronic, intractable pain,’ a condition that
constitutes a chronic physical impairment which substantially limits one or more major life
activities,” consistent with subheading 9817.00.96, HTSUS. Erikson also argues that the device
has no “curative value for the disease that caused the pain, and can only be used for analgesic
purposes.” Therefore, Erikson states that the Scrambler Therapy is an ”adaptive device that
allows a handicapped person to function,” by temporarily relieving chronic pain.
With the submission, Erikson provided several documents demonstrating what types of
conditions the device is designed to treat. The Scrambler Therapy’s instruction manual states that
it is indicated for three broad categories of pain:
• Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute
pain.
• Symptomatic relief of acute pain.
• Symptomatic relief of post-operative pain
The “setup guide” provided by the Erikson states that the Scrambler Therapy device is
designed to specifically treat “chronic neuropathic pain.” The guide notes that “[a]lthough some
studies suggest Scrambler Therapy® (ST) may have benefits for acute pain, patients with
mechanical or acute pain are not currently considered ideal candidates-unless their condition is
being managed solely for pain relief.” As an example, it states that someone diagnosed with
“Diabetic Neuropathy Pain” would be an ideal candidate, whereas a person with “Bulging Disk
Pain” would be a bad candidate. In an additional flier for the product, Erikson lists eight specific
underlying conditions as “indications for use:”
• Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Chronic Cancer Pain
• Chronic Neuropathic Pain
• Failed Back Surgery Syndrome (FBSS)
• Sciatic and Lumbar Pain
• Postherpetic Neuralgia (PHN) Brachial Plexus Neuropathy
• Low Back Pain (LBP)
• Chronic Neuropathic Pain Opioid Addiction
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Furthermore, on Erikson’s public facing website, the device is advertised as a solution to
“neurologic and/or oncologic chronic pain.” The website displays an additional list of 19
underlying conditions for which Scrambler Therapy may be effective in treating “…and many
more:”
• Diabetic Peripheral Neuropathy
• Brachial Plexus Neuropathy
• Non cancer pain such as neuropathic back pain
• Sciatic and Lumbar Pain
• Low Back Pain (LBP)
• Endometriosis
• Post-mastectomy Pain
• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Bone Metastases
• Failed Back Surgery Syndrome (FBSS)
• Chronic Neuropathic Pain Opioid Addiction
• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Pancreas and Abdominal Cancer Pain
• Chronic Cancer Pain
• Brachial Plexus Neuropathy
• Complex Regional Pain Syndrome (CRPS)
• Post-Herpetic Pain (Shingles pain)
• Chronic Neuropathic Pain
• Spinal Cord Stenosis
Erikson also provided an article from the New England Journal of Medicine describing
how the Scrambler Therapy device operates and its effectiveness. The article indicates that the
Scrambler Therapy was “[d]esigned specifically for chronic neuropathic and cancer pain,
especially opioid-resistant pain.” It further notes that “[b]eneficial effects have been reported to
persist for weeks, months, or years after sessions.”
ISSUE:
Whether the Scrambler Therapy Model ST-5A device is eligible for duty-free treatment
under subheading 9817.00.96, HTSUS.
LAW AND ANALYSIS:
Subheading 9817.00.96, HTSUS, came into effect in the United States through a series of
international agreements and acts of Congress. Its basis is in the Agreement on the Importation
of Educational, Scientific and Cultural Materials, opened for signature Nov. 22, 1950, 17 U.S.T.
1835, 131 U.N.T.S. 25, or Florence Agreement, drafted by the United Nations Educational,
Scientific, and Cultural Organization (“UNESCO”) in July 1950. In 1976, UNESCO adopted the
Nairobi Protocol to the Florence Agreement, which expanded the scope of products to include
materials specially designed for handicapped persons. See Protocol to the Agreement on the
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Importation of Educational, Scientific, or Cultural Materials, opened for signature 1 Mar. 1977,
1259 U.N.T.S. 3. Congress ratified the Nairobi Protocol and enacted it into U.S. law in 1983.
Pub. L. 97-446, § 161, 96 Stat. 2329, 2346 (1983). Section 1121 of the Omnibus Trade and
Competitiveness Act of 1988 (Pub. L. No. 100-418, 102 Stat. 1107) and Presidential
Proclamation 5978 implemented the Nairobi Protocol by inserting permanent provisions such as
subheading 9817.00.96 into the HTSUS.
Subheading 9817.00.96, HTSUS, provides for: “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.”
U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS, states that 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(b), Subchapter XVII, Chapter 98,
HTSUS states that subheading 9817.00.96 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.”
The issue of what constitutes a “therapeutic” article under the Nairobi Protocol was
addressed in Richards Medical Co. v. United States, 720 F. Supp. 998 (CIT 1989), aff'd, 910
F.2d 828 (Fed.Cir.1990), which held that “therapeutic” articles are those that are used to heal
or cure the condition causing a handicap, as opposed to those articles which are designed to
compensate for, or adapt to, the handicapped condition.
Thus, classification within subheading 9817.00.96, HTSUS, depends on whether a
product is “specially designed or adapted for the use or benefit of the blind or other physically or
mentally handicapped persons,” and whether it falls within any of the enumerated exclusions
under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
At issue here is whether Scrambler Therapy device is “specially designed or adapted”
for” the use or benefit of handicapped persons, i.e. persons who have a permanent or chronic
physical impairment, and not an acute or transient disability.
The HTSUS does not establish a clear definition of what constitutes “specially designed
or adapted for the use or benefit” of handicapped persons. The Court of the International Trade
(“CIT”) has stated that it might rely upon its own understanding of the terms or consult
dictionaries and other reliable information. See Danze, Inc. v. United States, 319 F. Supp. 3d
1312 (CIT 2018). In Sigvaris, Inc. v. United States, 899 F.3d 1308, 1314-15 (Fed. Cir. 2018),
the Court of Appeals for the Federal Circuit (“CAFC”) clarified:
.. [W]e must ask first, “for whose, if anyone’s, use and benefit is the article specially
designed,” and then, “are those persons physically handicapped?” …
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We conclude that, to be “specially designed,” the subject 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. This definition of “specially designed” is consistent with factors that
Customs uses in discerning for whose use and benefit a product is “specially designed.”
Customs considers “the physical properties of the merchandise, whether the merchandise
is solely used by the handicapped, the specific design of the merchandise, the likelihood
the merchandise is useful to the general public, and whether the merchandise is sold in
specialty stores.”… These factors aid in assessing whether the subject merchandise is
intended for the use or benefit of a specific class of persons to a greater extent than for the
use or benefit of others. Accordingly, we adopt them in our analysis ….
In Sigvaris, 899 F.3d at 1315, the compression hosiery was designed for people who had
“tired, achy, heavy feeling in their legs” and who were sitting for a long time. The advertising
material demonstrated that the merchandise was generally designed for the use or benefit of a
variety of persons, including those who lead an active lifestyle, are in professions that require
sitting for long periods of time, are pregnant, or desire fashionable hosiery. The CAFC
concluded that the hosiery was not specially designed for the use or benefit of a specific class of
persons, and that the court did not need to assess if the persons who might use the subject
merchandise were physically handicapped.
Consistent with CAFC’s holding in Sigvaris, we must first determine for whose, if
anyone’s, use and benefit is the scrambler device “specially designed.” To determine the
meaning of the phrase “specially designed or adapted,” CBP evaluates the following factors,
which the CAFC has adopted in Sigvaris, supra: 1) physical properties of the article itself (e.g.,
whether the article is easily distinguishable in design, form and use from articles useful to non-
handicapped persons); (2) presence of any characteristics 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) importation by manufacturers or distributors recognized or proven to be
involved in this class or kind of articles for the handicapped; (4) sale in specialty stores that serve
handicapped individuals; and (5) indication at the time of importation that the article is for the
handicapped. See Headquarters Ruling Letter (“HQ”) H304676, dated Mar. 26, 2020.
In Headquarters Ruling Letter (HQ) 563002, dated May 26, 2004, CBP stated that “[a]s
permanent or chronic pain substantially limits one or more major life activities, particularly
working, persons suffering from permanent or chronic pain are considered physically
handicapped as that term is defined in U.S. Note 4(a) to Subchapter XVI.” However, it rejected
the importer’s claim that “drug pump pouches” were “specially designed or adapted for the
handicapped” because the protestant failed to provide any evidence that the general public was
unlikely to use the product.
In HQ H330926, dated February 2, 2024, transducer arrays used as part of a Novocure
Therapy Delivery System, by cancer patients suffering chronic pain, were not eligible for duty
free treatment under 9817.00.96, because CBP determined that cancer does not constitute a
permanent or chronic physical impairment as described by Note 4(b)(i) to Subchapter XVII. CBP
noted that cancer “as a disease that is often treatable, disabilities resulting from the illness fit
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within the definition of ‘acute or transient disabilt[ies],’ and as such, articles that are designed for
acute or transient disability are specifically excluded from subheading 9817.00.96.”
In this case, Erikson has failed to demonstrate that the Scrambler Therapy device is
“specially designed” for the handicapped, rather than a medical device designed to treat severe
pain more generally. Erikson claims that the device is “specially designed for the handicapped”
because it treats chronic pain which is a “physical impairment which substantially limits one or
more major life activities.” Although CBP has stated in HQ 563002, that chronic pain may
constitute a handicap, acute or transient pain is specifically excluded under Note 4(b)(i),
Subchapter XVII, Chapter 98, HTSUS.
We are unconvinced that the Scrambler Therapy device would primarily be used to treat
long term chronic pain, and not also severe shorter-term acute pain. On its website, Erikson lists
19 underlying conditions causing pain, for which Scrambler Therapy is effective in treating, as
well as “many more.” At least several of the underlining conditions, including various types of
cancer pain, could take the form of short term acute or transit pain, treatable by surgery or other
therapies. 1 In HQ H330926, CBP previously noted that while cancer is a serious disease, it is
often treatable and therefore “specifically excluded from subheading 9817.00.96.” Furthermore,
the Scrambler Therapy’s instruction manual directly states that the Scrambler Therapy is
indicated for “[s]ymptomatic relief of acute pain.” While Erikson’s separate flier claims that
“patients with mechanical or acute pain” are normally not considered ideal candidates, it also
implies that they may be ideal candidates if “their condition is being managed solely for pain
relief.” Additionally, there appear to be no restrictions that would prevent members of the public
from using the product to treat severe pain generally, and nowhere in Erikson’s documentation or
website is the Scrambler Therapy device ever directly marketed for “handicapped” or “disabled”
individuals. Accordingly, Erikson has not shown that the Scrambler Therapy device is “specially
designed” for the handicapped.
Finally, the device is possibly therapeutic, and therefore excluded from duty free
treatment under subheading 9817.00.96, HTSUS. As mentioned in Richard Medical, therapeutic
articles are those that “…are used to heal or cure the condition causing a handicap, as opposed to
those articles which are designed to compensate for, or adapt to, the handicapped condition.”
Erikson disputes that the device is therapeutic, claiming, that Scrambler Therapy only provides
short term “systematic relief,” however Erikson’s website promotes a testimonial from a doctor
at John Hopkins stating: “it’s effective, it’s non-invasive, it reduces opioid use substantially and
it can be permanent.” A typical Scrambler Therapy treatment lasts only 10 consecutive sessions,
over two weeks, with booster cycles only provided as needed, and research shared by the Erikson
from the New England Journal of Medicine indicates that “effects have been reported to persist
for weeks, months, or years after sessions.” This leads us to believe that in many instances the
Scrambler Therapy device is therapeutic, by permanently blocking pain signals.
1
See Endometriosis, The Clevland Clinic, (Accessed Nov. 24, 2025),
https://my.clevelandclinic.org/health/diseases/10857-endometriosis; Lower Back Pain (LBP) (Accessed Nov. 24,
2025), https://my.clevelandclinic.org/health/diseases/7936-lower-back-pain; Larry Parker, Failed Back Surgery
Syndrome (FBSS): What It Is and How to Avoid Pain after Surgery, Spine-health (Jun. 7, 2023). https://www.spine-
health.com/treatment/back-surgery/failed-back-surgery-syndrome-fbss-what-it-and-how-avoid-pain-after-surgery.
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HOLDING:
Based upon the information submitted, the Scrambler Therapy ST-5A device is not
eligible for duty-free treatment under subheading 9817.00.96, HTSUS.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
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