OT:RR:NC:N3:135
Stephen Chan
CEFALY US Inc
19 Old Kings Hwy S Suite 200
Darien, CT 06820
RE: The country of origin of a CEFALY Connected kit
Dear Mr. Chan:
In your letter dated July 8, 2025, you requested a country of origin ruling on the CEFALY Connected kit.
The CEFALY Connected kit (SKU 10801) is intended for both the acute treatment and preventive therapy of
migraines in adults. The imported set includes one main device (CEFALY Connected), a charging dock, a kit
of three reusable adhesive electrodes, a resealable electrode bag, USB charging cable, a plastic carrying case,
user manuals, quick start guide, and packaging. The CEFALY Connected (main device) generates the
treatment signal that is sent to stimulate and desensitize the trigeminal nerve. The user applies a reusable
adhesive electrode to the forehead and attaches the main device magnetically. Upon activation, the device
delivers mild electrical pulses to the ophthalmic branch of the Trigeminal nerve.
The main device consists of a top cover, a button cover, a rubber butter, a plastic switch, a main printed
circuit board assembly (PCBA), a battery, a flex PCBA assembly, a conductive spring, two flex PCB
mountings, two t-shape magnets, a conductive metal part, a EVA upper side, left side, and right side of
battery, a back housing, and a device label. The electrode is made in Taiwan. The charging dock, cable,
carrying case, and remaining items of the kit are made in China.
The PCBAs of the main device are manufactured and programmed with firmware in Taiwan. This firmware,
developed in Belgium, enables the therapeutic functionality of the device. It governs the main device
operation, which is the defining purpose of the product. The firmware upload transforms the inert hardware
into an operational medical device.
The PCBA production process in Taiwan includes:
Mounting of electrical components onto the two sides of the main PCB and flex PCBs via Surface
Mount Technology (SMT)
Verifying component placement and solder quality on the populated boards using Automated Optical
Inspection (AOI) system
Integrating the main board and flex board into a single assembly
Loading firmware into the memory of the main PCBA
Testing
Storing completed PCBAs pending shipment
Production process in China:
All PCBAs of the main device are then transported to China, where they are assembled into the final housing.
This step includes connecting the PCBA to a rechargeable battery, integration with the mechanical button and
enclosure, and final enclosure sealing and packaging.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
Based on the information presented, the functionality of the CEFALY Connected (main device) is driven by
its main PCBA and flex PCBA, which are manufactured in Taiwan. The assembly of the PCBAs and
programming operations performed in Taiwan substantially transform the individual components into a
product of Taiwan. The assembly process performed in China does not constitute a complex and meaningful
operation, and therefore, does not result in a substantial transformation. As such, the country of origin of the
CEFALY Connected (main device) will be Taiwan. The CEFALY Connected kit will be classified as a set
per General Rule of Interpretation 3 (b) and the main device will impart the essential character of the set.
Accordingly, the country of origin of the kit for duty purposes will be Taiwan.
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