FDA.reportPublic FDA data

Tradeflex Flexion Table

Primary DI
00850008449888
Brand
Tradeflex Flexion Table
Company
PIVOTAL HEALTH SOLUTIONS, INC.
Model
E9018-L
Published
2021-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008449888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008449888008500084498888500084498880850008449888

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.

Regulatory Flags#

DUNS number
826316098
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
00850008449871Tradeflex Flexion TableE90182021-08-27
00850008449918Tradeflex Flexion TableE92182021-08-27
00850008449925Tradeflex Flexion TableE9218-L2021-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544065COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-08-17
00810045933306Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
00810045933313Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
00810045933320Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
00810045933337Clinton IndustriesCLINTON INDUSTRIES, INC.INQ2026-07-29
06975582543938COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543945COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543952COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543969COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543976COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543983COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
06975582543990COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.INQ2026-07-06
00854798000793Torque TablePIVOTAL HEALTH SOLUTIONS, INC.INQ2026-05-27
00815235022631UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022655UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022662UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022679UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022686UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022693UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022709UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022716UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022723UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022730UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022747UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022754UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022761UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022778UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022785UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022792UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14
00815235022808UMF MedicalUNITED METAL FABRICATORS, INC.INQ2026-05-14