FDA.reportPublic FDA data

Therm-X

Primary DI
00850001096393
Brand
Therm-X
Company
ZENITH TECHNICAL INNOVATIONS, LLC
Model
Therm-X Back Garment
Catalog number
TX0105
Device description
Therm-X Back Garment (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
00850001096393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001096393008500010963938500010963930850001096393

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature33 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature33 Degrees Fahrenheit122 Degrees Fahrenheit

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
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
00850001096478Therm-XTherm-X Split Umbilical HoseTX02082026-02-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
04719893351026WellellWellell Inc.JOW2026-03-17
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184925CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
08809315676984LF900DAESUNG MAREF CO.,LTD.IRP2023-03-08
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08809315672252SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
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08809315672276SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
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08809315672290SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672306SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
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08809315672382SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672399SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672405SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672412SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315671866SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671873SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671880SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671897SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15