510(k) K900647

SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC by Nor-Am Patient Care Products, Inc. — Product Code IPF

K900647 is an FDA 510(k) premarket notification submitted by Nor-Am Patient Care Products, Inc. for the device "SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC". The FDA issued a decision of Substantially Equivalent on Oct 22, 1990. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Nor-Am Patient Care Products, Inc. has 6 other 510(k) clearances on record.