510(k) K904264

MODEL SW-103 SOLITANS STIMULATOR by Medical Consultants Intl. , Ltd. — Product Code GZJ

K904264 is an FDA 510(k) premarket notification submitted by Medical Consultants Intl. , Ltd. for the device "MODEL SW-103 SOLITANS STIMULATOR". The FDA issued a decision of Substantially Equivalent on May 9, 1991. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Consultants Intl. , Ltd. has at least 5 other 510(k) clearances on record.