510(k) K944487

ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES by Prizm Medical, Inc. — Product Code GXY

K944487 is an FDA 510(k) premarket notification submitted by Prizm Medical, Inc. for the device "ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Prizm Medical, Inc. has at least 7 other 510(k) clearances on record.