IOPI®

Basic Information

• Brand Name: IOPI®
• Primary DI: 10810091040284
• Version / Model: Report Generator v 1.0
• Catalog Number: 5-8101
• Company Name: Iopi Medical LLC
• Labeler DUNS: 828391396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-21
• Public Version: 1
• Public Version Date: 2025-03-31
• Public Version Status: New
• Public Device Record Key: eb6f1464-b736-4e24-bca5-e79f60b30e56

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKE	Transducer, Miniature Pressure	Physical Medicine	890.1615	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63454	Dynamometer 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810091040291	GS1	5-8101_EN	1	In Commercial Distribution
Primary	10810091040284	GS1
Package	10810091040581	GS1	5-8101_ES	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]