Bioelectronics Corp (BIEL)

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The PEMF Market Continues to Heat-Up

The FDA just created a new PEMF category for high powered, OTC, PEMF machines under Product Code 'SGT'.
There is only one product currently Cleared, Aurawave, with a $12k price tag. This lowering of regulations on PEMF by the FDA could help BIEL get a more powerful wearable device Cleared.

Product Classification
Device electromagnetic stimulator for healthy muscle stimulation
Regulation Description Powered muscle stimulator.
Definition
A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.
Physical State The device generally includes a magnetic stimulator, a stimulation coil, and other accessories.
Technical Method The device uses a magnetic coil to produce a time-varying magnetic field, which induces a secondary electric field in the targeted tissues, which, in turn, non-invasively, temporarily increases local blood flow and stimulates healthy muscles.
Target Area The device generally targets muscles of the arms, legs, back, and/or buttocks.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product Code SGT
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting Ineligible
Implanted Device? No
Life-Sustain/Support Device? No

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=5708

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.