510(k) K895473

DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S by Medical Devices, Inc. — Product Code GZJ

K895473 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S". The FDA issued a decision of Substantially Equivalent on December 8, 1989. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.