FDA 510(k) Application Details - K231368

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K231368
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Bemer INT AG Austrasse 15 Triesen 9495 LI Other 510(k) Applications for this Company
Contact	Sandra Schwarzenberger 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	05/11/2023
Decision Date	06/09/2023
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