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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K252187
Device Name Aura Glide (FC40)
Applicant
Aura Medical, LLC
2 Skillman St., Suite 512
Brooklyn,  NY  11205
Applicant Contact Connie Lefkowitz
Correspondent
Gpw Enterprises, LLC
47 Gatehouse Rd.
Bedminster,  NJ  07921
Correspondent Contact Gina Walljasper
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Codes
OHS   OLP  
Date Received07/14/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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