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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Aura Wellness, LLC has one other decision in the tracker over the last 12 months: K262788 (Nova HD+).

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

Sources