FDA 510(k) Application Details - K201257

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K201257
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Arrive Systems Inc 113 Brakdale New Ark, DE 19711 US Other 510(k) Applications for this Company
Contact	Aseem Gupta 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	05/11/2020
Decision Date	04/06/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review