KardiaMobile 6L Personal EKG Monitor from Japan
A six-lead personal ECG monitor that pairs with smartphones to detect atrial fibrillation and other arrhythmias alongside blood pressure correlation features. Falls under HTS 9018.19.95.30 for electro-diagnostic basal metabolism and blood pressure apparatus. FDA-cleared for over-the-counter use.
Duty Rate — Japan → United States
12.5%
Rate breakdown
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Include FDA OTC clearance letter and app store links proving medical software integration
• Label as 'electro-diagnostic apparatus' to distinguish from fitness trackers under Chapter 95
• Document clinical accuracy studies; customs may request proof of medical vs consumer classification