510(k) K010638

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 by Vermont Medical, Inc. — Product Code GXY

K010638 is an FDA 510(k) premarket notification submitted by Vermont Medical, Inc. for the device "NEUROPLUS, MODEL A10040, A10041, A10042, A10043". The FDA issued a decision of Substantially Equivalent on May 3, 2001. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Vermont Medical, Inc. has at least 8 other 510(k) clearances on record.