OT:RR:NC:N3:135
Kayla Owens
Stein Shostak Shostak Pollack & O'Hara
445 S. Figueroa Street, Suite 2388
Los Angeles, CA 90071
RE: The country of origin of a fingertip pulse oximeter
Dear Ms. Owens:
In your letter dated January 6, 2026, you requested a country of origin ruling on a fingertip pulse oximeter on
behalf of your client, Choice MMed America. Additional information was provided via email dated January
21 and January 23, 2026.
OxyWatch C1F Fingertip Pulse Oximeter is a handheld, battery-powered device intended for checking blood
oxygen saturation and the pulse rate of users. It has a digital display that shows an individual’s SpO2 level
and pulse rate. The main components of the device are a power supply printed circuit board assembly
(“PCBA”), a blood oxygen PCBA, a housing, and an LCD screen. Raw materials for the production of the
fingertip pulse oximeter are sourced from China, including unpopulated (“bare”) printed circuit boards
(PCBs), electronic components (resistors, capacitors, IC, crystal oscillators, etc.), screens, structural materials
(injection-molded housings, springs, lenses, back adhesives, etc.), and packaging materials (packaging boxes,
manuals, back stickers, etc.).
Description of the manufacturing process in Vietnam:
1). Perform the SMT (Surface Mount Technology) mounting processing on unpopulated (“bare”) Power
PCBs and Blood oxygen PCBs;
2). Perform SN code laser engraving for subsequent circuit board traceability;
3). Print solder paste onto the PCB through a printing machine, and detect the quality of solder paste printing
using an SPI (Solder Paste Inspection) device;
4). Use a chip mounter to mount components, then cure the components and solder paste through a reflow
oven;
5). After completion, conduct AOI (Automated Optical Inspection) to ensure the components mounting effect
and no mounting defects;
6). For power boards, further process by welding springs;
7) Inspect and separate boards;
8). For oximeter boards, after they pass AOI(Automated Optical Inspection), they undergo corresponding
product inspections before being put into production;
9). Assembly of the oximeter;
During the assembly process, first, the factory will program the power supply PCBA and blood
oxygen PCBA. Then they will complete the screen welding process and finally fix the screen. Next,
they will thread the power board FPC wire through the middle shell and weld it to the power board.
They will then fix the lower shell, completing the installation of electrode pads and hanging springs
with the power board. Subsequently, they will fasten the middle shell and lower shell together and
complete the hanging springs and upper and lower rubber pad operations. After installing the upper
shell and lens, they will test the product's performance. Once the test passes, they will conduct an
appearance inspection and then hand over the product to the quality inspector for verification.
10). Packaging operations after passing quality inspection; and
11). Print the corresponding labels according to the order requirements and complete the packaging
operations.
The finished product will be exported from Vietnam to the United States.
When determining the country of origin for purposes of applying current trade remedies under Section 301
and additional duties, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling
Letter 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).
Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every
article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly,
indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to
indicate to the ultimate purchaser in the United States, the English name of the country of origin of the
article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to
know by an inspection of the marking on the imported goods the country of which the goods is the product.
The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by
knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should
influence his will.” See United States v. Friedlaender & Co., 27 C.C.P.A. 297, 302 (1940).
Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the
country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP
Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or
growth of any article of foreign origin entering the United States. Further work or material added to an article
in another country must effect a substantial transformation in order to render such other country the “country
of origin” within the meaning of the marking laws and regulations.
In this case, the blood oxygen and power supply printed circuit board assemblies are made in Vietnam using
Surface Mount Technology. The overall assembly process in Vietnam completes the fingertip pulse oximeter.
The blood oxygen PCBA is critical to the function of the device and imparts the essence of the finished
article. Based on the totality of the circumstances, we find that the SMT, downloading, and assembly, taken
together, constitute a substantial transformation and the country of origin for the subject fingertip pulse
oximeter will be Vietnam for marking and duty purposes.
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)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division