IOPI®

Basic Information

• Brand Name: IOPI®
• Primary DI: 10810091040246
• Version / Model: Model 3.2
• Catalog Number: 8-3201
• 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: 3
• Public Version Date: 2025-09-16
• Public Version Status: Update
• Public Device Record Key: 995c0c4c-d7df-4c74-9c4c-46f2b60ac325

Device Description

The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Trainer is intended for clinical use and use by patients outside their therapy sessions under the direction of a healthcare professional.

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: Yes
• Has Lot/Batch Number: No
• 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	10810091040277	GS1	1-3200_EN	1	In Commercial Distribution
Primary	10810091040246	GS1
Package	10810091040482	GS1	1-3200_ES	1	In Commercial Distribution
Package	10810091040796	GS1	R-1-3201	1	Not in Commercial Distribution	2025-09-15
Package	10810091040833	GS1	R-1-3201	1	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 65 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius