The country of origin of an automatic upper arm blood pressure monitor

N355175 November 12, 2025 OT:RR:NC:N3:135 CATEGORY: Origin Sheryl Lu Jamr Technology Company Ltd. No.2, Lot A-7-CN, N6 road, My Phuoc Industrial Park, Ben Cat Ward Ho Chi Minh City 820000 Vietnam RE: The country of origin of an automatic upper arm blood pressure monitor Dear Ms. Lu: In your letter dated October 22, 2025, you requested a country of origin ruling. The item under consideration is a Fully Automatic Upper Arm Blood Pressure Monitor (Model Number: C02), designed for the indirect measurement of human blood pressure. This device employs the oscillometric method, taking measurements during the inflation phase. The main unit of the device consists of a Printed Circuit Board Assembly (PCBA Main Board), an LED display screen, an air pump, an exhaust valve, a plastic housing, and various non-critical materials, such as, lens (protects the display screen from scratches and stains), springs, wires, screws, brackets, foam, metal, domes, pump covers, O-rings, tubing, silicone pads, etc. The main unit is packaged with a cuff, a USB-C power cord, a storage bag, and a user’s manual in a retail box. You summarize the function of the device as follows: Under the control of a Microcontroller Unit (MCU) in the PCBA, the air pump inflates the cuff at a specific rate while the pressure signals are analyzed in real-time. After the results are calculated by the algorithm, the exhaust valve is immediately activated for rapid deflation, and the systolic pressure, diastolic pressure, and pulse rate readings are displayed simultaneously on the LED screen. The PCBA Main Board, LED display screen, plastic housing, user’s manual, and boxes are produced in Vietnam. The air pump, exhaust valve, cuff, power cord, auxiliary materials, labels and other packaging materials are made in China. The blood pressure monitor device undergoes four key component production and assembly processes in Vietnam: A. PCBA Manufacturing; B. LED Display Manufacturing; C. Housing Injection Molding, and D. Blood Pressure Monitor Final Assembly and Testing. A. PCBA Main Board Production (Vietnam Factory A): A.1 Main Board SMT: Major electronic components including the, MCU, sensor, fuse, capacitors, resistors, diodes, transistors, USB port, etc., are mounted onto the surface of the PCB using Surface Mount Technology (SMT). Automated Optical Inspection (AOI) equipment checks the placement quality of the post-SMT. A.2 Firmware Burning: Firmware files are burned into the MCU's memory using programming equipment. A.3 Main Board Testing: Specialized performance test equipment and tools are used to conduct comprehensive performance tests on the finished PCBA Main Board to ensure full functionality. B. LED Display Screen Production (Vietnam Factory A): B.1 Light Board SMT (PCBA): Major electronic components including the resistors, capacitors, LEDs, inductors, ICs, transistors, etc., are mounted onto the surface of the circuit board (PCB) using SMT. AOI equipment checks the placement quality. B.2 Light Board Processing: The PCBA is assembled onto the LED bracket. After assembly, the combination is placed into a heat staking machine where the fixing posts on the LED bracket are melted and solidified to secure the assembly. A light guide film is then attached to the heat-staked assembly, forming the LED Display Screen. B.3 Light Board Testing: Specialized performance test equipment and tools are used to conduct comprehensive performance tests on the PCBA Light Board to ensure full functionality. C. Plastic Housing Production (Vietnam Factory A): C.1 Housing Injection Molding: The corresponding mold is installed in the injection molding machine. Plastic raw material is added to the machine, and key process parameters are set. Heated, molten plastic is injected into the mold and cools to form the parts. C.2 Housing Inspection: Parts are inspected, and qualified products are selected. D. Assembly Process Description (Vietnam Factory B): The final assembly, testing, packaging, and inspection of the Fully Automatic Upper Arm Blood Pressure Monitor are completed in another Vietnamese factory, Factory B. This factory is responsible for all incoming material inspection, assembly manufacturing, in-process testing, product packaging, and final product inspection. The manufacturing process is as follows: D.1 Housing Component Processing: Inspect housing parts and assemble/weld corresponding components to form housing sub-assemblies. D.2 Main Board Calibration and Processing: Calibrate the PCBA Main Board using calibration equipment, which involves writing multiple standard pressure values into the MCU. Subsequent processing steps are performed after calibration. D.3 Main Board and LED Display Screen Installation: Install the LED Display Screen and PCBA Main Board into the front cover, and connect them by soldering flexible flat cables (FFCs). D.4 Air Pump Component Installation: Solder wires, assemble components including the air pump, Exhaust Valve, and tubing into a module, and install it into the rear cover. D.5 Wire Soldering: Solder or insert wires into the connectors on the PCBA Main Board. D.6 Final Assembly: The housing components, mainboard, light board, air pump module, and other parts are assembled together to build the main unit of the blood pressure monitor. D.7 Semi-Finished Product Testing: Perform tests on semi-finished products, including startup/shutdown current test, air tightness and pressure comparison test, and blood pressure simulation test. Products passing these tests are selected as functionally qualified. D.8 Visual Inspection: Inspect the product appearance and select products with qualified appearance. D.9 Product Packaging: Package the product and its accessories into finished goods according to order requirements. D.10 Final Product Inspection: After packaging, conduct final product inspection to ensure the finished goods are qualified. D.11 Finished Goods Warehousing: Store qualified finished products in the warehouse. 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). You state that the PCBA Main Board is responsible for controlling all functions and components of the electronic blood pressure monitor, processing signals, and calculating blood pressure values. The LED display screen is used to display measurement results such as blood pressure and pulse rate to the user. Under the MCU control, the air pump inflates the cuff to increase its pressure for arterial compression. The cuff is used to apply and sense pressure on the arm during measurement. The exhaust valve, under the MCU control, opens rapidly after measurement is complete to quickly deflate the cuff. Customs and Border Protection (“CBP”) has consistently held that the assembly of components onto a printed circuit board utilizing the Surface Mount Technology (SMT) results in a substantial transformation. See HQ ruling 735306, dated December 21, 1993, and HQ ruling H302801, dated October 3, 2019. In this case, the main and light board assemblies are completed in Vietnam using Surface Mount Technology. The blank Microcontroller Unit (MCU) is programmed in Vietnam using firmware. This process enables the PCBA Main Board to perform the essential functions of the blood pressure monitor. Furthermore, the overall assembly process in Vietnam completes the blood pressure monitor. The PCBA Main Board 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 all together constitute a substantial transformation and the country of origin for the subject blood pressure monitor will be Vietnam for duty purposes. However, since the cuff is merely packaged with the monitor, the cuff does not undergo a substantial transformation. The country of origin of the cuff remains China. Therefore, for the purposes of marking, the countries of origin of the blood pressure monitor will be Vietnam and China. 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 fei.chen@cbp.dhs.gov. Sincerely, (for) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division