510(k) K011913

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES by Sun-Rain System Corp. — Product Code IPF

K011913 is an FDA 510(k) premarket notification submitted by Sun-Rain System Corp. for the device "SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES". The FDA issued a decision of Substantially Equivalent on October 26, 2001. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Sun-Rain System Corp. has at least 2 other 510(k) clearances on record.