FDA.reportPublic FDA data

iTrac

Primary DI
00852753008952
Brand
iTrac
Company
PIVOTAL HEALTH SOLUTIONS, INC.
Model
T9010
Device description
iTrac, 230V
Published
2018-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILZAccessories, Traction
IRSHead Halter, Traction
ITHEquipment, Traction, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILZAccessories, TractionPhysical Medicine1
IRSHead Halter, TractionPhysical Medicine1
ITHEquipment, Traction, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852753008952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852753008952008527530089528527530089520852753008952

GMDN Terms#

Term, Definition table
TermDefinition
Traction table, line-poweredA mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826316098
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854798000793Torque TableTT10002026-05-27
00854798000526Elevating Hand Therapy TableHT1002026-03-27
00854798000533Elevating Hand Therapy TableHT2002026-03-27
00854798000571Elevating Hand Therapy TableHT9002026-03-27
00854798000588Elevating Hand Therapy TableHT17002026-03-27
00854798000601Elevating Hand Therapy TableHT19002026-03-27
00854798000656Elevating Hand Therapy TableREV1002026-03-27
00854798000663Elevating Hand Therapy TableREV2002026-03-27
00854798000670Elevating Hand Therapy TableREV9002026-03-27
00854798000748Elevating Hand Therapy TableREV17002026-03-27
00854798000762Elevating Hand Therapy TableREV19002026-03-27
00854798000786Portable Parallel BarsPTPB-10002026-03-27
00854798000465Parallel Bars Electric Platform MountEPB10080-NE2026-01-22
00854798000472Parallel Bars Electric Platform MountEPB10080B-NE2026-01-22
00854798000489Parallel Bars Electric Platform MountEPB10010-NE2026-01-22
00854798000496Parallel Bars Electric Platform MountEPB10010B-NE2026-01-22
00854798000502Parallel Bars Electric Platform MountEPB10012-NE2026-01-22
00854798000519Parallel Bars Electric Platform MountEPB10012B-NE2026-01-22
00850020142446AE Elevating Treatment TableA4201-EL2025-08-12
00854798000298Parallel Bars Electric Platform MountEPB100802025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888912296533CHATTANOOGADJO, LLCILZ2024-08-20
00860000487573Antalgic TrakANTALGIC-TRAKITH2024-07-11
00630094171470Bioseal Inc.BIOSEALILZ2023-09-18
10630094171477Bioseal Inc.BIOSEALILZ2023-09-18
00630094163604Bioseal Inc.BIOSEALILZ2023-09-13
00630094163635Bioseal Inc.BIOSEALILZ2023-09-13
00630094163642Bioseal Inc.BIOSEALILZ2023-09-13
00630094163659Bioseal Inc.BIOSEALILZ2023-09-13
00630094163666Bioseal Inc.BIOSEALILZ2023-09-13
00630094163727Bioseal Inc.BIOSEALILZ2023-09-13
10630094163601Bioseal Inc.BIOSEALILZ2023-09-13
10630094163632Bioseal Inc.BIOSEALILZ2023-09-13
10630094163649Bioseal Inc.BIOSEALILZ2023-09-13
10630094163656Bioseal Inc.BIOSEALILZ2023-09-13
10630094163663Bioseal Inc.BIOSEALILZ2023-09-13
10630094163724Bioseal Inc.BIOSEALILZ2023-09-13
04260676050082RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04260676050099RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04719871180297EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ITH2023-08-24
04719871180372EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180389EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180396EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180402EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04053815083344clTracZimmer MedizinSysteme GmbHITH2023-06-05
00888912268806CHATTANOOGADJO, LLCILZ2023-04-18
00888912268851CHATTANOOGADJO, LLCILZ2023-04-18
00888912258746CHATTANOOGADJO, LLCILZ2022-12-01
00850020142378Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00850020142385Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00850020142392Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11