510(k) K250896— Aura Wave

Substantially Equivalent

Aura Wellness, LLC

Clearance details

Applicant: Aura Wellness, LLC
Product code: Code SGT
Advisory panel: Physical Medicine
Date received: 2025-03-25
Decision date: 2025-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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