K250896
- 510(k) number
- K250896
- Device name
- Aura Wave
- Applicant
- Aura Wellness, LLC KY · US
- Product code
- SGT — Electromagnetic Stimulator For Healthy Muscle Stimul
- Decision date
- 2025-12-02
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250896.pdf
Official FDA record: K250896
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.