IOPI®

Basic Information

• Brand Name: IOPI®
• Primary DI: 10810091040048
• 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: 2022-10-20
• Public Version: 1
• Public Version Date: 2022-10-28
• Public Version Status: New
• Public Device Record Key: 875dec1b-8cbe-486a-837b-1ab7d75aa8be

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 and dysarthria. The IOPI® Trainer is intended for clinical or home use by patients under the direction of a medical 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	10810091040024	GS1	Kit (1-3200_EN)	1	In Commercial Distribution
Primary	10810091040048	GS1
Package	10810091040178	GS1	Kit (1-3200_ES)	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