510(k) K040986

CADWELL LIMB MOVEMENT MODULE by Cadwell Laboratories, Inc. — Product Code LEL

K040986 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "CADWELL LIMB MOVEMENT MODULE". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.