510(k) K801709

BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF by Fred Sammons, Inc. — Product Code KNO

K801709 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.