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Shockim Enterprises, Ltd.
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RHYTHM TOUCH Q 2-WAY is an FDA 510(k)-cleared medical device (K032178) manufactured by Shockim Enterprises, 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 14, 2003. Regulation: 8.