K250896 is an FDA 510(k) clearance for the Aura Wave. This device is classified as a Electromagnetic Stimulator For Healthy Muscle Stimulation (Class II - Special Controls, product code SGT).
Submitted by Aura Wellness, LLC (Louisville, US). The FDA issued a Cleared decision on December 2, 2025, 252 days after receiving the submission on March 25, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850. 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..
| 510(k) Number | K250896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2025 |
| Decision Date | December 02, 2025 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | SGT - Electromagnetic Stimulator For Healthy Muscle Stimulation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |
| 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. |