Loading…
Neurotris, Inc. dba A1 Engineering manufactured and distributed Class II Powered Muscle Stimulator devices (including the SX2500 Picowave, SX3800, SX4500, SVX650, and PICO Toner models) without required premarket approval (PMA) or 510(k) clearance, rendering the products adulterated and misbranded under federal law. An FDA inspection conducted April 4-25, 2023 identified these violations, and the company's May 6, 2023 response was found inadequate to address the deficiencies. The devices were being marketed and distributed for medical purposes including muscle stimulation and body treatment without the necessary regulatory authorization.