FDA WARNING_LETTER - Zona Health Inc. - December 06, 2019

The FDA issued a Warning Letter to Zona Health, Inc. on December 6, 2019, regarding the Zona Plus device. The FDA determined the Zona Plus, marketed as a handheld isometric exercise device, is adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

The device is adulterated because it is marketed without premarket approval (PMA) for its intended use of controlling and/or reducing blood pressure. It is misbranded because it was introduced into interstate commerce for a use different from legally marketed devices under 21 CFR 890.5380 (Powered Exercise Equipment) without a required 510(k) premarket notification. The Zona Plus was previously found not substantially equivalent (NSE) in 2010 for blood pressure reduction, automatically classifying it as a Class III device requiring PMA.

Furthermore, the device is misbranded due to misleading representations on the company's website (zona.com) implying official FDA approval, such as "FDA Cleared" and linking to an "active listing" for establishment registration, which does not denote product approval. The FDA had previously informed Zona Health, Inc. in teleconferences (November 15, 2018, and February 13, 2019) to remove blood pressure claims and patient testimonials, but these statements persist.

The FDA requires Zona Health, Inc. to immediately cease activities resulting in the mis