510(k) K250896

Device

Aura Wave

Applicant

Aura Wellness, LLC

510(k) number

K250896

Product code

SGT

Decision

Substantially Equivalent (SESE)

Decision date

2025-12-02

Date received

2025-03-25

Regulation

890.5850

Classification name

Electromagnetic Stimulator For Healthy Muscle Stimulation

Medical specialty

Physical Medicine

Review panel

Physical Medicine

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N