Wellness Center USA Inc (WCUI)

[Atlanta1]

Item 8 - Other Events.



On July 2, 2020, the Company received notice from the U.S. Food & Drug Administration (“FDA”) stating that the FDA has reviewed the Section 510(k) premarket notification of intent to market filed by the Company’s subsidiary, Psoria-Shield, Inc. (“PSI”), for PSI’s AURORA device and has determined that the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, that do not require approval of a premarket approval application (PMA), and may therefore, market the device, subject to the general controls provisions of the Act. The AURORA device is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.