
Acute Ideas Co. , Ltd.
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RUMBLE TUFF is an FDA 510(k)-cleared medical device (K113315) manufactured by Acute Ideas Co. , Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2012. Regulation: 8.

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