FDA.reportPublic FDA data

Ultium

Primary DI
00816271020391
Brand
Ultium
Company
Noraxon U.S.A., Inc.
Model
810C
Device description
Ultium EMG Sensor Tape
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816271020391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816271020391008162710203918162710203910816271020391

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

Regulatory Flags#

DUNS number
611243809
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816271020377Noraxon2622026-03-30
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
00816271020773Core8842026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11
10192253046304KendallCardinal Health 200, LLCKGX2024-05-29