510(k) K902822

MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE by Medical Design & Manufacturing Corp. — Product Code GZJ

K902822 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE". The FDA issued a decision of Substantially Equivalent on December 19, 1990. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.