Aura Wave
FDA 510(k) clearance K250896 · decided 2025-12-02
Clearance details
- K-number
- K250896
- Device name
- Aura Wave
- Applicant
- Aura Wellness, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-03-25
- Decision date
- 2025-12-02
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- SGT
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.