DeviceClearance

Product code SGT— Physical Medicine

Aura Wave

Classification name
Electromagnetic Stimulator For Healthy Muscle Stimulation
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SGT under 21 CFR 890.5850, via openFDA

Market context for product code SGT

FDA has cleared 2 devices under product code SGT between 2025 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SGT

Recent clearances under product code SGT

Data sourced from openFDA. This site is unofficial and independent of the FDA.