FDA 510(k) Application Details - K243165

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K243165
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	EYWA srl Via Pietrarubbia n. 25/E n. 25/E Rimini 47922 IT Other 510(k) Applications for this Company
Contact	Tommaso Faiella 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	09/30/2024
Decision Date	05/15/2025
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	N
Expedited Review