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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K220938
Device Name Nova HD+
Applicant
Aura Wellness, LLC
11530 Electron Drive
Louisville,  KY  40299
Applicant Contact Scott Blomberg
Correspondent
Aura Wellness, LLC
11530 Electron Drive
Louisville,  KY  40299
Correspondent Contact Scott Blomberg
Regulation Number890.5850
Classification Product Code
NGX  
Date Received03/31/2022
Decision Date 08/22/2023
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
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