FDA.reportPublic FDA data

Therm-X

Primary DI
00850001096478
Brand
Therm-X
Company
ZENITH TECHNICAL INNOVATIONS, LLC
Model
Therm-X Split Umbilical Hose
Catalog number
TX0208
Device description
Therm-X Split Umbilical Hose (005.00)
Published
2026-02-13
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
ILOPack, Hot Or Cold, Water Circulating
IRPMassager, Powered Inflatable Tube
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IRPMassager, Powered Inflatable TubePhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001096478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001096478008500010964788500010964780850001096478

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable hot/cold therapy pack/electric pumpA non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062931546
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001096386Therm-XTherm-X ATTX00022026-02-13
00850001096393Therm-XTherm-X Back GarmentTX01052026-02-13
00850001096409Therm-XTherm-X Knee GarmentTX01022026-02-13
00850001096416Therm-XTherm-X Ankle GarmentTX01042026-02-13
00850001096423Therm-XTherm-X Elbow GarmentTX01032026-02-13
00850001096430Therm-XTherm-X Shoulder GarmentTX01012026-02-13
00850001096447Therm-XTherm-X Hip GarmentTX01082026-02-13
00850001096454Therm-XTherm-X XL Shoulder GarmentTX01102026-02-13
00850001096461Therm-XTherm-X Half-Leg GarmentTX01112026-02-13
00850001096485Therm-XTherm-X Extender StrapsTX01092026-02-13
00850001096492Therm-XTherm-X Hand GarmentTX01122026-02-13
00850001096508Therm-XTherm-X HOMETX03002026-02-13
00850001096515Therm-XTherm-X Shoulder SPUTX03012026-02-13
00850001096522Therm-XTherm-X Knee SPUTX03022026-02-13
00850001096539Therm-XTherm-X Ankle SPUTX03042026-02-13
00850001096546Therm-XTherm-X Hip SPUTX03082026-02-13
00850001096553Therm-XTherm-X Back SPUTX03052026-02-13
00850001096560Therm-XTherm-X Hand SPUTX03122026-02-13
00850001096577Therm-XTherm-X Butterfly Knee Small, SPUTX03152026-02-13
00850001096584Therm-XTherm-X Butterfly Knee Large, SPUTX03142026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911676N/AShenzhen Urion Technology Co., LtdIRP2026-07-24
00850087597081Recovery+ Go Compression UnitWMI ENTERPRISES, LLCIRP2026-07-23
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21