FDA 510(k) Application Details - K143458

Device Classification Name	Orthosis, Limb Brace   More FDA Info for this Device
510(K) Number	K143458
Device Name	Orthosis, Limb Brace
Applicant	Neurospectrum LLC 3 Crown Crt Rancho Mirage, CA 92270 US Other 510(k) Applications for this Company
Contact	David Kernan Other 510(k) Applications for this Contact
Regulation Number	890.3475   More FDA Info for this Regulation Number
Classification Product Code	IQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2014
Decision Date	08/13/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review