FDA cleared the Nova HD+ from Aura Wellness, LLC on Aug 31, 2026 under K262788, a special 510(k). The device falls under product code SGT, Electromagnetic Stimulator For Healthy Muscle Stimulation, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.
FDA logged the submission as received on Aug 6, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).
Aura Wellness, LLC has one other decision in the tracker over the last 12 months: K250896 (Aura Wave).