510(k) K250896
K250896 is an FDA 510(k) premarket notification submitted by Aura Wellness, LLC for the device "Aura Wave". The FDA issued a decision of Substantially Equivalent on Dec 2, 2025. The device falls under product code SGT (Electromagnetic Stimulator For Healthy Muscle Stimulation), a Class II device regulated under 21 CFR 890.5850. Aura Wellness, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2025
- Date Received
- Mar 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromagnetic Stimulator For Healthy Muscle Stimulation
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
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.