FDA 510(k) Application Details - K223797

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K223797
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Neuro20 Technologies 3802 Spectrum Blvd Suite 116E Tampa, FL 33626 US Other 510(k) Applications for this Company
Contact	Dennis Schmitt Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2022
Decision Date	02/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review