FDA 510(k) Application Details - K243290

Device Classification Name	Stimulator, Muscle, Powered, Dental   More FDA Info for this Device
510(K) Number	K243290
Device Name	Stimulator, Muscle, Powered, Dental
Applicant	BTL Industries, Inc. 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	NUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	05/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review