510(k) K760618

PATIENT RESTRAINT by Encompass Group, LLC — Product Code FMQ

K760618 is an FDA 510(k) premarket notification submitted by Encompass Group, LLC for the device "PATIENT RESTRAINT". The FDA issued a decision of Substantially Equivalent on Nov 24, 1976. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Encompass Group, LLC has 3 other 510(k) clearances on record.