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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K252767
Device Name actiTENS mini
Applicant
Sublimed
137 Rue Mayoussard
Moirans,  FR 38430
Applicant Contact Adrien Hallet
Correspondent
Medical Device Academy
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NGX   NUH   NYN  
Date Received08/29/2025
Decision Date 01/16/2026
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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