Aura Wave
FDA 510(k) K250896 · Aura Wellness, LLC
510(k) numberK250896
Submission
- Device name
- Aura Wave
- Applicant
- Aura Wellness, LLC
Louisville, KY, US - Received
- March 25, 2025
- Decision date
- December 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SGT – Electromagnetic Stimulator For Healthy Muscle Stimulation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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.
Other 510(k)s with product code SGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262788 | Nova HD+SGT · Special | Aura Wellness, LLC | 08/31/2026SE |
More from Aura Wellness, LLC
Questions and answers
When was Aura Wave cleared by the FDA?
Aura Wave (K250896) received a 510(k) decision of Substantially Equivalent on December 2, 2025, 252 days after the submission was received.
What is the product code of K250896?
The FDA product code is SGT – Electromagnetic Stimulator For Healthy Muscle Stimulation, a Class II (moderate risk) device regulated under 21 CFR 890.5850.