SGT

Electromagnetic Stimulator For Healthy Muscle Stimulation

Product code
SGT
Device name
Electromagnetic Stimulator For Healthy Muscle Stimulation
Device class
Class 2
21 CFR
21 CFR 890.5850
Medical specialty
Physical Medicine
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-12-02.

NumberDecision dateApplicantDevice nameSummary
K2508962025-12-02Aura Wellness, LLCAura WavePDF

1 summaries are archived here for direct download.

Official FDA classification page: SGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).