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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 K252712
Device Name STIMPOD NMS460 Nerve Stimulator
Applicant
Algiamed Technologies USA, Inc.
801 International Pkwy. 5th Floor
Lake Mary,  FL  32746
Applicant Contact Irina Proutski
Correspondent
Algiamed Technologies USA, Inc.
801 International Pkwy. 5th Floor
Lake Mary,  FL  32746
Correspondent Contact Irina Proutski
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/27/2025
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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