OT:RR:NC:N1:105
Misty Gibbins
Pacific Customs Brokers Inc.
2150 Peace Portal Dr.
Blaine, WA 98230
RE: The eligibility under the Nairobi Protocol of the Lumia system from China
Dear Ms. Gibbins:
In your letter dated April 1, 2025, on behalf of your client, Lumia Health, you requested a ruling to determine
the eligibility of the Lumia system under the Nairobi Protocol.
The item under consideration is described as the Lumia system, which is a system designed to fit in the
cymba concha of the outer ear and provides biometric data to the user. The device utilizes infrared light to
non-invasively assess blood flow through a branch of the posterior auricular artery located in the ear,
enabling it to track blood flow to the head. By shining light on this artery, Lumia captures a blood flow
waveform, which is used to measure the heart rate and blood flow.
The device consists of three primary physical subsystems. The earpiece measures biometric data and
transmits it to the docking station. It is primarily made of printed circuit board assemblies (PCBAs), molded
plastic housings, and an injection molded outer silicone jacket. The docking station relays the earpiece data to
the cloud where additional data analysis is done and transmits to the mobile app. The docking station has a
base PCBA, LED PCBA, and an injection molded plastic housing. The carrying case protects the earpiece
when not in use and is made of an injection-molded plastic housing.
According to your letter, the Lumia device is intended exclusively for individuals with chronic blood flow
disorders and conditions, and the purchasing process incorporates a qualifier survey to ensure that only
eligible buyers can proceed. Those who do not meet the criteria are blocked from purchase, ensuring that
credit cards are not charged. You additionally state that unlike standard wearables that measure heart rate
through green light, capturing blood flow signals in shallow capillaries at the wrist or finger, Lumia
specifically targets arterial signals at the head, providing users, particularly those with chronic blood flow
disorders, a better understanding of how their lifestyle choices impact their symptoms.
In your request, you ask if the Lumia system is “eligible for importation under the Nairobi Protocol SPI.”
The United States, one of the signatories, has implemented part of the United Nations Nairobi Protocol,
currently, via a provision for a secondary classification for articles for the handicapped in Harmonized Tariff
Schedule of the United States (HTSUS) 9817.00.92 through 9817.00.96 and US Note 4 to Subpart 17 to
Chapter 98.
From the information provided, you state the Lumia system obtains biometric data insights for individuals
suffering from chronic conditions such as postural orthostatic tachycardia syndrome (POTS), orthostatic
hypotension, orthostatic intolerance, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and
long COVID. You further claim that the device’s location makes obtaining the information unique because it
is specifically obtaining the information from the head region.
The issue is whether the Lumia system is “specially designed or adapted” for the use or benefit of
handicapped persons, which is required by the superior text in subheading 9817.00.96, HTSUS. The meaning
of the phrase “specially designed or adapted” has been decided on a case-by-case basis. In Headquarters
ruling 556449, dated May 5, 1992, Customs set forth factors it would consider in making this case-by-case
determination. These factors include: 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.
In your letter, you state that the Lumia system has a design that sets it apart in the wearable market by
utilizing a unique placement that differentiates it from other biometric devices. However, we find that the
wearable device captures very similar data to that of other wearable devices and does not appear to be
specific to blood disorders. Your letter further claims that Lumia’s extensive design and utility patents
(W02022056241A1 and W02022056247A1) along with several pending patents (US20230355187A1),
reiterates their specific use. Again, while the design of the product allows it to be positioned on the body in a
unique way, it does not provide data that other wearable devices cannot capture. Despite the location of the
device, the information would be very similar to other wearables, which are not limited to use for permanent
or chronic physical impairments that substantially limit one or more major life activities. Further, the Lumia
system does not have any identifying features that would make it solely usable for people with the blood and
heart disorders listed above.
Accordingly, in our view, the Lumia system does not satisfy the description set forth in Chapter 98,
Subchapter XVII, U.S. Note 4(a). Therefore, the secondary classification under subheading 9817.00.96,
HTSUS, would not apply to the Lumia system.
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 Jason Christie at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division