510(k) K261442

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array by Cadwell Industries, Inc. — Product Code GXY

K261442 is an FDA 510(k) premarket notification submitted by Cadwell Industries, Inc. for the device "Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array". The FDA issued a decision of Substantially Equivalent on Jun 26, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Cadwell Industries, Inc. has 12 other 510(k) clearances on record.