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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 K213655
Device Name HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
Applicant
Hilltek, LLC
421 S Brookhurst St.; Suite 142
Anaheim,  CA  92804
Applicant Contact Mohammadali Nezakati
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received11/19/2021
Decision Date 01/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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