510(k) K852298

TENS-AID STERILE ELECTRODES FOR POST-OP TENS by Staodynamics, Inc. — Product Code GXY

K852298 is an FDA 510(k) premarket notification submitted by Staodynamics, Inc. for the device "TENS-AID STERILE ELECTRODES FOR POST-OP TENS". The FDA issued a decision of Substantially Equivalent on June 24, 1985. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Staodynamics, Inc. has at least 10 other 510(k) clearances on record.