
Domino S.R.L.
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GLOBUS PREMIUM MUSCLE STIMULATOR is an FDA 510(k)-cleared medical device (K061632) manufactured by Domino S.R.L.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 2007. Regulation: 8.