N334538

N334538 September 5, 2023 OT:RR:NC:N3:135 CATEGORY: Origin Olga Torres Torres Trade Law, PLLC 1201 Main St, Suite 1350 Dallas, TX 75202 RE: The country of origin, application of Section 301 trade remedies, and marking of two digital blood pressure monitors Dear Ms. Torres: In your letter dated August 7, 2023, you requested a country of origin, application of Section 301trade remedies, and marking ruling on behalf of Microlife Corporation. Photographs, bills of materials, and manufacturing process steps accompanied your inquiry. A marked sample was not submitted with your request. The products under consideration are two automatic digital blood pressure monitors (the “BPMs”): 1) Model No. BP3KC1 - worn on the wrist for measurement (hereinafter referred to as the “wrist BPM”) and 2) Model No. BP3NG1 - worn on the upper arm (hereinafter referred to as the “upper arm BPM”). In both models, a Micro Controller Unit (“MCU”) connected to a miniature air pump and valve system controls cuff inflation and deflation to change cuff pressure and facilitate blood pressure measurements. The inflated cuff senses pressure waveforms generated by cardiac contraction and relaxation and transmits these waveforms via the tube to the internal pressure sensor, which provides the input signal for estimation of systolic and diastolic blood pressure via the processing unit. Both BPMs contain an acrylonitrile butadiene styrene (“ABS”) plastic case housing electronic components, an LCD screen to display the measurement, a six-volt battery power adaptor, a buzzer, and other components. For the wrist BPM, the monitoring device is locked to the cuff, whereas for the upper arm BPM, the cuff is an independent component that is not locked to the monitoring device. A summary of the manufacturing processes are provided below. MANUFACTURING PROCESS OF WRIST BPM The wrist BPM model is assembled in Vietnam using parts from China, Taiwan, Japan, and Vietnam, including the cuff made in China and a printed circuit board assembly (“PCBA”) made in Vietnam. Firmware designed in Taiwan is burned into the MCU in Vietnam. The hardware and mechanism, as well as basic software/firmware source code are all designed in Taiwan. After completion of the design and development in Taiwan, all the manufacturing processes for the wrist BPM occur in Vietnam. The PCBA is assembled in Vietnam using components from Taiwan, China, Japan, and Vietnam. The parts of the BPM, including the MCU for running the blood pressure program, are assembled into a PCBA via Surface Mount Technology (“SMT”) and Chip on Board (“COB”) technology. The SMT machining process consists of (1) printing the solder paste on the surface of two pieces of PCB; (2) mounting 28 SMT parts in the correct position on the PCB; (3) soldering the parts to the PCB using a hot air soldering furnace; and (4) checking the welding using Auto Optical Inspection (“AOI”) equipment. Next, the COB process requires the gluing of the MCU to the PCBA and connecting the MCU to the PCBA with precision bonding equipment. After connection, AOI equipment is used to check the accuracy of the connection, then epoxy resin is used to seal the MCU and wire. Finally, the SMT and COB are processed using the In-Circuit Test and the Functional Verification Tester. Final processing of the wrist BPM occurs at another factory in Vietnam. That Vietnamese factory is responsible for inspection of all incoming materials, module processing, “program burning” and “feature option burning,” which is the key process to enable the PCBA to perform the function of the BPM, final product assembly, inspection, packaging, and marking of the wrist BPM. The module assembly process involves joining together the components into the following module blocks: 1. Lower case cover module, consisting of an LED indicator, battery spring, and buzzer; 2. Pump and air circuit path module, requiring assembly of the pump, air valve, and air circuit; 3. Upper case cover assembly, consisting of the upper cover and buttons; and 4. LCD and PCBA assembly, which is the assembled LCD and PCBA with conductive zebra paper spliced into the module with hot melt equipment. The final product assembly stage consists of (1) assembling the PCBA, air path, and case; (2) calibrating the pressure sensor; (3) a function test; and (4) pressure accuracy testing. MANUFACTURING PROCESS OF UPPER ARM BPM Similarly, the upper arm BPM hardware and basic software/firmware source code are designed in Taiwan. After the completion of the design and development in Taiwan, all the manufacturing processes for the upper arm BPM occur in Vietnam. The PCBA is assembled from components from Taiwan, China, Japan, and Vietnam in a Vietnamese factory. The parts of the BPM, including the MCU for running the blood pressure program, are assembled into a PCBA via Surface Mount Technology (“SMT”) and Chip on Board (“COB”) technology as described above. Finally, the factory ensures the SMT and COB are processed correctly using the In-Circuit Test and the Functional Verification Tester. Final processing of the upper arm BPM occurs at another factory in Vietnam. That Vietnamese factory is responsible for inspection of all incoming materials, module processing, “program burning” and “feature option burning,” finished product assembly, inspection, packaging and marking of the upper arm BPM. The module processing includes: 1. Air path module assembly, consisting of the air path, quick release valve, and slow release valve; 2. Bottom assembly, requiring the welding of flat signal cables to the PCBA; 3. Battery connector assembly, requiring the welding of the power cable to the positive/negative battery spring; 4. Pump assembly, requiring welding of the power cable with the pump and adding shock-absorbing foam to the pump; 5. LCD module assembly, consisting of the LCD and a conductive strip on the LCD holder; and 6. Upper cover module, consisting of the upper cover and I/O (on/off) buttons. The finished product assembly involves: 1. PCBA welding and assembly; 2. Calibrating the pressure sensor; 3. Assembling key materials into the lower case; 4. Assembling the air path conduit and locking the case sections; 5. Completing the device pressure calibration; 6. Testing function; 7. Testing pressure accuracy; 8. Inspecting appearance COUNTRY OF ORIGIN AND SECTION 301 APPLICABILITY "Country of origin" is defined in 19 CFR 134.1(b) 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 this part.” A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993). However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983). Substantial transformation determinations are based on the totality of the evidence. See Headquarters Ruling (HQ) W968434, date January 17, 2007, citing Ferrostaal Metals Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987). The issue of whether a substantial transformation occurs is determined on a case by case basis. See HQ 561353, dated September 19, 2002. HQ ruling H241177, dated December 3, 2013, states “the programming of a device that defines its use generally constitutes substantial transformation.” Customs and Border Protection (“CBP”) has consistently held that the assembly of component