FDA 510(k) Application Details - K200382

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K200382
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	BTL 362 Elm Street Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	David Chmel 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	02/18/2020
Decision Date	01/06/2021
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