FDA 510(k) Application Details - K250146

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K250146
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Sofwave Medical Ltd. 1 Ha-Otsma St. Yokneam Ilit 2069200 IL Other 510(k) Applications for this Company
Contact	Ruthie Amir 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	01/21/2025
Decision Date	04/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review