AliveCor Kardia Pro Remote Monitoring System from China
Cloud-connected ECG and blood pressure monitoring platform for remote patient management with physician dashboard. Classified HTS 9018.19.95.30 as electro-diagnostic apparatus. Includes wearable sensor.
Duty Rate — China → United States
35%
Rate breakdown
9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
9903.88.0125%Except as provided in headings 9903.88.05, 9903.88.06, 9903.88.07, 9903.88.08, 9903.88.10, 9903.88.11, 9903.88.14, 9903.88.19, 9903.88.50, 9903.88.52, 9903.88.58, 9903.88.60, 9903.88.62, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(a) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(b) [to this subchapter]
Import Tips
• Classify as medical device including Software as Medical Device (SaMD)
• FDA cybersecurity documentation increasingly required at import
• Wireless components don't shift to Chapter 85 if principal medical function