510(k) K962778

THE L-BOW ARM RESTRAINT by Heelbo, Inc. — Product Code FMQ

K962778 is an FDA 510(k) premarket notification submitted by Heelbo, Inc. for the device "THE L-BOW ARM RESTRAINT". The FDA issued a decision of Substantially Equivalent on October 9, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Heelbo, Inc. has at least 10 other 510(k) clearances on record.