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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, for muscle conditioning
510(k) Number K223797
Device Name Neuro20 Pro System
Applicant
Neuro20 Technologies
3802 Spectrum Blvd Suite 116E
Tampa,  FL  33626
Applicant Contact Dennis Schmitt
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
IPF  
Date Received12/19/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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