Clearance Summary
Aura Wave received FDA 510(k) clearance under submission number K250896, sponsored by Aura Wellness, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-12-02.
- Submission: K250896
- Applicant / Sponsor: Aura Wellness, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2025-12-02
Classification & Regulation
This clearance is catalogued under FDA product code SGT and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.