510(k) K911366

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE by Medical Design & Manufacturing Corp. — Product Code GXY

K911366 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.