FDA 510(k) Application Details - K213655

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K213655
Device Name	Stimulator, Muscle, Powered
Applicant	HillTek LLC 421 S Brookhurst Street; Ste#142 Anaheim, CA 92804 US Other 510(k) Applications for this Company
Contact	Mohammadali Nezakati Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2021
Decision Date	01/17/2023
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