FDA WARNING_LETTER - WAVi Co. - March 29, 2023

On October 20, 2023, the FDA issued a Warning Letter to WAVi Co. following a March 2023 inspection. The inspection revealed that WAVi Co. manufactures and distributes the "WAVi Desktop," a device intended for neurological assessment and diagnosis, without required FDA approval. The device is considered adulterated and misbranded because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application, and failed to submit a premarket notification (510(k)).

Despite WAVi Co.'s claim that the device is for "research use only," FDA found evidence of commercial distribution and clinical use through customer lists, website testimonials, and "find a practitioner" features promoting its use in "brain spas," "heart institutes," and "medical spas" for conditions like head injury, depression, ADHD, and anxiety.

The inspection also identified several Quality System Regulation (QSR) violations, including: 1. **Failure to validate device software (21 CFR 820.30(g)):** WAVi Co. distributed non-validated "WAVi Desktop research software" with AI capabilities. 2. **Failure to validate processes (21 CFR 820.75(a)):** The Electrical Processing Unit (EPU) Test Fixture, used to verify EPU functionality, was not qualified or validated. 3. **Failure to maintain adequate