FDA.reportPublic FDA data

IOPI®

Primary DI
10810091040048
Brand
IOPI®
Company
Iopi Medical LLC
Model
Model 3.2
Catalog number
8-3201
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.
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
10810091040024PackageGS11Not in Commercial Distribution
10810091040178PackageGS11Not in Commercial Distribution
10810091040048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009104002410810091040024
1081009104017810810091040178
1081009104004810810091040048

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius65 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
828391396
Device count
1
Premarket exempt
true
Serial number
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
10810091040055IOPI®Report Generator v 1.05-81012022-10-20
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
10810091040055IOPI®Iopi Medical LLCIKE2022-10-20
10810091040000IOPI®Iopi Medical LLCIKE2022-10-20
10810091040024IOPI®Iopi Medical LLCIKE2022-10-20
10810091040062IOPI®Iopi Medical LLCIKE2022-10-20