Accuracy Statement: higi Station and SH-650 Health Station
Overview & Regulatory Context
higi SH LLC (higi) is a certified Quality Management System and Medical Device Standards (ISO 13485) company. It complies with all regulations associated with the design, manufacturing and distribution of health monitoring tools.
In addition to ISO certification, higi medical device products receive FDA clearance (via the 510k process) prior to market introduction in the USA.
To view our Accuracy Statement click here.