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Ito Co., Ltd.
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US-100 PORTABLE ULTRASOUND THERAPY UNIT is an FDA 510(k)-cleared medical device (K032793) manufactured by Ito Co., Ltd.. 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 October 8, 2003. Regulation: 8.