FDA 510(k) Application Details - K214037

Device Classification Name	Equipment, Traction, Powered   More FDA Info for this Device
510(K) Number	K214037
Device Name	Equipment, Traction, Powered
Applicant	Ergo-Flex Technologies, LLC 13622 Poplar Circle Conroe, TX 77304 US Other 510(k) Applications for this Company
Contact	Linda Anderson Other 510(k) Applications for this Contact
Regulation Number	890.5900   More FDA Info for this Regulation Number
Classification Product Code	ITH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2021
Decision Date	02/22/2024
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