FDA.reportPublic FDA data

IOPI®

Primary DI
10810091040253
Brand
IOPI®
Company
Iopi Medical LLC
Model
Model 3.1
Catalog number
8-3101
Device description
The IOPI® Pro (Model 3.1) is used by healthcare professionals to 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. The IOPI® Pro is intended for clinical use by healthcare professionals.
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10810091040253PackageGS11In Commercial Distribution
10810091040260PackageGS11In Commercial Distribution
10810091040321PackageGS11In Commercial Distribution
10810091040420PackageGS11In Commercial Distribution
10810091040239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009104025310810091040253
1081009104026010810091040260
1081009104032110810091040321
1081009104042010810091040420
1081009104023910810091040239

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828391396
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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
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
10810091040055IOPI®Iopi Medical LLCIKE2022-10-20
10810091040000IOPI®Iopi Medical LLCIKE2022-10-20
10810091040024IOPI®Iopi Medical LLCIKE2022-10-20
10810091040062IOPI®Iopi Medical LLCIKE2022-10-20