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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromagnetic Stimulator For Healthy Muscle Stimulation
510(k) Number K250896
Device Name Aura Wave
Applicant
Aura Wellness, LLC
2208 Plantside Dr.
Louisville,  KY  40299
Applicant Contact Scott Blomberg
Correspondent
Aura Wellness, LLC
2208 Plantside Dr.
Louisville,  KY  40299
Correspondent Contact Scott Blomberg
Regulation Number890.5850
Classification Product Code
SGT  
Date Received03/25/2025
Decision Date 12/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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