510(k) K032954

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 by Danmeter A/S — Product Code IPF

K032954 is an FDA 510(k) premarket notification submitted by Danmeter A/S for the device "ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80". The FDA issued a decision of Substantially Equivalent on August 9, 2004. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Danmeter A/S has at least 3 other 510(k) clearances on record.