510(k) K823640

BATH TUB SAFETY BAR by Fred Sammons, Inc. — Product Code IKX

K823640 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BATH TUB SAFETY BAR". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.