510(k) K831542

ADJUSTABLE POLYCENTRIC ELBOW HINGE by Fred Sammons, Inc. — Product Code IQI

K831542 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ADJUSTABLE POLYCENTRIC ELBOW HINGE". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.