FDA.reportPublic FDA data

IOPI®

Primary DI
10810091040055
Brand
IOPI®
Company
Iopi Medical LLC
Model
Report Generator v 1.0
Catalog number
5-8101
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.
Published
2022-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKETransducer, Miniature Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKETransducer, Miniature PressurePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810091040062PackageGS11Not in Commercial Distribution
10810091040185PackageGS11Not in Commercial Distribution
10810091040055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009104006210810091040062
1081009104018510810091040185
1081009104005510810091040055

GMDN Terms#

Term, Definition table
TermDefinition
Dynamometer force gaugeAn 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.

Contacts#

Phone, Email table
PhoneEmail
425-549-0139info@iopimedical.com

Regulatory Flags#

DUNS number
828391396
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810091040246IOPI®Model 3.28-32012025-03-21
10810091040031IOPI®Model 3.18-31012022-10-20
10810091040048IOPI®Model 3.28-32012022-10-20
10810091040239IOPI®Model 3.18-31012025-03-21
10810091040284IOPI®Report Generator v 1.05-81012025-03-21
10810091040253IOPI®Model 3.18-31012025-03-21
10810091040277IOPI®Model 3.28-32012025-03-21
10810091040291IOPI®Report Generator v 1.05-81012025-03-21
10810091040000IOPI®Model 3.18-31012022-10-20
10810091040024IOPI®Model 3.28-32012022-10-20
10810091040062IOPI®Report Generator v 1.05-81012022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810091040239IOPI®Iopi Medical LLCIKE2025-03-21
10810091040246IOPI®Iopi Medical LLCIKE2025-03-21
10810091040284IOPI®Iopi Medical LLCIKE2025-03-21
10810091040253IOPI®Iopi Medical LLCIKE2025-03-21
10810091040277IOPI®Iopi Medical LLCIKE2025-03-21
10810091040291IOPI®Iopi Medical LLCIKE2025-03-21
00816271020797myoRESEARCHNoraxon U.S.A., Inc.IKE2023-06-07
10810091040031IOPI®Iopi Medical LLCIKE2022-10-20
10810091040048IOPI®Iopi Medical LLCIKE2022-10-20
10810091040000IOPI®Iopi Medical LLCIKE2022-10-20
10810091040024IOPI®Iopi Medical LLCIKE2022-10-20
10810091040062IOPI®Iopi Medical LLCIKE2022-10-20