FDA Clears Aura Wave by AuraWell in Newly Created PEMF Category Bringing Clinical-Grade Recovery Home for the First Time

AuraWell Offers Two FDA-Cleared Devices Now Available for Home or Clinical Use

LOUISVILLE, KY, UNITED STATES, December 16, 2025 /EINPresswire.com/ -- A new era of recovery and performance enhancement has arrived! The female-led medical device company, AuraWell, has officially launched its latest innovation: the Aura Wave. In addition, a newly established FDA category has cleared the Aura Wave as the first high powered over the counter frequency therapy device. This historic clearance makes clinical-grade technology available at home for the first time ever, bringing powerful recovery support to consumers and professionals alike.

“This FDA clearance represents a historic moment not just for AuraWell, but for the entire wellness and recovery industry,” states Alane Paulley, CEO of AuraWell. “We fought for years to create a clear regulatory pathway for consumer wellness, and we succeeded! The FDA has now established a brand-new device category, and The Aura Wave is the first product ever cleared under it. What was once limited to clinics is now accessible at home. This is more than a clearance,... it’s a turning point.”

AuraWell’s story is rooted in innovation. Paulley’s father originally pioneered PEMF technology for equine athletes in Kentucky’s horse country. When Paulley took the helm in 2012, she transformed the technology - making it travel-friendly, cost-effective, and truly accessible. A former television producer and mother of three, she is driven by compassion and a mission to help others live without pain. Her leadership has propelled MagnaWave, a sister company of AuraWell, into the Inc. 5000 list of fastest-growing companies, with all production proudly based in the USA.

The Aura Wave device increases local blood circulation, stimulates muscles and enhances the delivery of oxygen and nutrients to tissue - all of which help support quicker recovery, reduced soreness, improved endurance, and faster performance gains. As the first device cleared under the FDA’s new Class II over-the-counter frequency therapy category, it brings true clinical-grade results into the home, giving users faster, more noticeable improvements in muscle recovery and overall wellness.

Frequency therapy has long been used by PGA players, NBA athletes, NFL teams, and elite performance centers, helping athletes recover faster, reduce inflammation, improve muscle readiness, and sustain a high level of training. Until now, these systems were largely confined to professional clinics and training rooms. With AuraWell’s advancements, everyday users can now experience the same elite-level recovery benefits, without clinic appointments, staff training, or downtime.

This is AuraWell’s second device launch, following the portable Nova HD+, which also provides a non-invasive, drug-free approach to supporting the body’s natural recovery process.

“This is going to be a total game changer and breakthrough that will help so many people,” Paulley added. “Now, everyday users can experience the same benefits professional athletes have relied on for years. Today, we’re blazing the wellness trail with an option that helps people live with less pain and recover quicker!”

As more people look for alternatives to invasive procedures or pharmaceuticals, the Aura Wave provides a science-backed, holistic solution. With it being the first consumer-ready, FDA-cleared device in its category, AuraWell is pioneering a new era of recovery - where advanced recovery technology isn’t just for hospitals or professional locker rooms, but for every home. For more information, visit www.AuraWell.com.

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About AuraWell
AuraWell, led by CEO Alane Paulley, is a privately owned wellness technology company dedicated to giving people a drug-free approach to injury recovery and illness prevention. Its FDA-cleared, clinical-strength PEMF devices are portable, hands-free, and easy to use. Delivering fast pain relief, without doctors, prescriptions or consumables. Compact and travel-friendly, AuraWell devices are designed for use at home or on the go. With flexible payment plans and a try-before-you-buy program, AuraWell makes elite-level wellness accessible to everyone. Put your health in your hands by learning more at www.AuraWell.com and watch powerful testimonials @AuraWellnessPEMF on Instagram. Relief Anytime, Anywhere.

Tracy Keyser
P2R Inc.
Tracy@P2Rinc.com
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