FDA 510(k) Application Details - K221865

Device Classification Name	Massager, Therapeutic, Electric   More FDA Info for this Device
510(K) Number	K221865
Device Name	Massager, Therapeutic, Electric
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	890.5660   More FDA Info for this Regulation Number
Classification Product Code	ISA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2022
Decision Date	04/14/2023
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	N
Expedited Review