FDA WARNING_LETTER - Neurotris, Inc. dba A1 Engineering - April 25, 2023

On October 27, 2023, the FDA issued a Warning Letter to Neurotris, Inc. following an inspection from April 4-25, 2023. The firm, a manufacturer and distributor of Class II Powered Muscle Stimulator devices (e.g., Neurotris SX/SVX Series, PICO Toner, and accessories), was found to be in violation of the Federal Food, Drug, and Cosmetic Act.

The devices, including SX2500 (Picowave), SX3800, SX4500, SVX650, PICO Toner, and various electrodes, gels, and sprays, are deemed adulterated and misbranded. Neurotris lacks approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications, and failed to submit premarket notifications (510(k)) for these devices. While a 510(k) (K182440) was cleared for the Body System (SX101 and 0S2911) for muscle conditioning, the currently marketed devices have different intended uses (e.g., nerve stimulation for aesthetic purposes, use on face/neck/chest) and technological characteristics (e.g., power sources, channels, accessories) that significantly differ from the cleared device, requiring new 510(k) submissions. Specific issues include the PICO Toner being marketed for