FDA.reportPublic FDA data

myoRESEARCH

Primary DI
00816271020797
Brand
myoRESEARCH
Company
Noraxon U.S.A., Inc.
Model
404
Catalog number
404
Device description
myoPRESSURE Software Module
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00816271020797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816271020797008162710207978162710207970816271020797

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used to detect and display a patient’s physical exercise/movements/actions, and sometimes provide performance feedback, while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology ambulatory recorder, as part of physical assessment/rehabilitation. It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing patient performance data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
611243809
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816271020377Noraxon2622026-03-30
00816271020391Ultium810C2026-03-30
00816271020407Ultium8022026-03-30
00816271020414Ultium8082026-03-30
00816271020421Ultium8112026-03-30
00816271020438Ultium8172026-03-30
00816271020445Ultium8202026-03-30
00816271020452Ultium8212026-03-30
00816271020469Ultium8242026-03-30
00816271020476Ultium8262026-03-30
00816271020483Ultium8292026-03-30
00816271020490Ultium8422026-03-30
00816271020506Ultium842X2026-03-30
00816271020513Ultium842Y2026-03-30
00816271020520Ultium8522026-03-30
00816271020537Ultium874E2026-03-30
00816271020681Ultium874D2026-03-30
00816271020698Ultium874HL2026-03-30
00816271020735Core8162026-03-30
00816271020766UltiumAPP012026-03-30

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
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