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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
510(k) Number K252893
Device Name ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
Applicant
Aneuvo
10940 Wilshire Blvd.
Suite 2030
Los Angeles,  CA  90024
Applicant Contact Amelia Striegel
Correspondent
Aneuvo
10940 Wilshire Blvd.
Suite 2030
Los Angeles,  CA  90024
Correspondent Contact Amelia Striegel
Classification Product Code
SDO  
Subsequent Product Code
GXY  
Date Received09/11/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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