510(k) K832546

MARK V HIGH VOLTAGE GALVANIC STIMULATORR by Orthion Corp. — Product Code IPF

K832546 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "MARK V HIGH VOLTAGE GALVANIC STIMULATORR". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Orthion Corp. has at least 10 other 510(k) clearances on record.