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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
510(k) Number K252816
Device Name High Tone Power therapy (HiToP) (Model: HiToP PNP)
Applicant
Mohammadali Nezakati
14929 Dickens St.
Sherman Oaks,  CA  91403
Applicant Contact Mohammadali Nezakati
Correspondent
Mohammadali Nezakati
14929 Dickens St.
Sherman Oaks,  CA  91403
Correspondent Contact Mohammadali Nezakati
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received09/04/2025
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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