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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K250896

510(k) cleared

Aura Wave

Aura Wellness, LLC · Dec 2, 2025 · K250896

FDA cleared the Aura Wave from Aura Wellness, LLC on Dec 2, 2025 under K250896, a traditional 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 Mar 25, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Aura Wellness, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250896?

K250896 is the FDA 510(k) for Aura Wave, submitted by Aura Wellness, LLC. FDA's decision date was Dec 2, 2025, under product code SGT (Electromagnetic Stimulator For Healthy Muscle Stimulation).

Who makes the Aura Wave?

Aura Wellness, LLC, based in Louisville, KY, is the applicant of record for K250896.

How long did the K250896 review take?

FDA received the submission on Mar 25, 2025 and issued its decision on Dec 2, 2025, 252 days later.

← All decisions in December 2025