FDA.reportPublic FDA data

Ultium

Primary DI
00816271020766
Brand
Ultium
Company
Noraxon U.S.A., Inc.
Model
APP01
Device description
Ultium EMG Biofeedback App
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816271020766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816271020766008162710207668162710207660816271020766

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). 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 and/or enable viewing of patient performance data.

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
00816271020773Core8842026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
06970670070334XFTShenzhen XFT Medical LimitedHCC2026-04-14
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020896UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020902UltiumNoraxon U.S.A., Inc.HCC2026-03-30