510(k) K021754

APEX MEDICAL DIGITAL EMS TS1311, TS1312 by Apex Medical Corp. — Product Code IPF

K021754 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL DIGITAL EMS TS1311, TS1312". The FDA issued a decision of Substantially Equivalent on June 28, 2002. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Apex Medical Corp. has at least 10 other 510(k) clearances on record.