FDA 510(k) Application Details - K131983

Device Classification Name	Equipment, Traction, Powered   More FDA Info for this Device
510(K) Number	K131983
Device Name	Equipment, Traction, Powered
Applicant	PIVOTAL HEALTH SOLUTIONS 724 OAKWOOD RD WATERTOWN, SD 57201 US Other 510(k) Applications for this Company
Contact	AARON TVEDT 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	06/28/2013
Decision Date	09/10/2014
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