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IOPI®

Report Generator v 1.0 · Iopi Medical LLC

IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only.

Details

Device typeDynamometer force gauge: An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.

FDA categoryTransducer, Miniature Pressure

Device ID10810091040284

Catalog number5-8101

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone425-549-0139

Emailinfo@iopimedical.com

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