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.

1 Comment

  1. Dave F.

    What happened to the Charities to which I donated my reward points to to help out with worthy causes? I don’t have any need for the discounted products, but I got a good feeling from helping out the less fortunate humans and animals by donating my points, I sincerely hope the Charities category for Higi points returns soon. Dave F.

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