Ivivi Technologies, Inc. Receives FDA 510(k) Clearance for its Latest Generation SofPulse, Roma3 and Torino II Electrotherapy Systems
12/15/2008 8:31:21 AM
MONTVALE, N.J., Dec. 15, 2008 (GLOBE NEWSWIRE) -- Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electrotherapy systems, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) Clearance for the Company's currently marketed targeted pulsed electromagnetic field (tPEMF(tm)) therapeutic products. The 510(k) Substantial Equivalence Determination specifically covers the Company's SofPulse Models 912-M10, Roma(3) and Torino II products which are indicated for the palliative treatment of post operative pain and edema in superficial soft tissue.
comments powered by