Aura Wave— 510(k) K250896
Substantially EquivalentAura Wellness, LLC
FDA 510(k) clearance K250896 for Aura Wave, Substantially Equivalent on 2025-12-02. Applicant: Aura Wellness, LLC. Device class: 2.
Clearance details
- Applicant
- Aura Wellness, LLC
- Product code
- Code SGT
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
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