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Iotamotion, Inc.
Free shipping on orders over $99 · 30-day returns
iotaSOFT Insertion System - Drive Unit, Controller and Accessories is an FDA 510(k)-cleared medical device (DEN190055) manufactured by Iotamotion, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 2021. Regulation: 8.

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