FDA.reportPublic FDA data

Therm-X

Primary DI
00850001096379
Brand
Therm-X
Company
ZENITH TECHNICAL INNOVATIONS, LLC
Model
Therm-X Butterfly Knee Small, SPU
Catalog number
TX0315
Device description
Therm-X Butterfly Knee Small, SPU
Published
2023-11-16
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231912000
K240125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231912000Therm-XZenith Technical Innovations2023-07-27IRP
K240125000Therm-X (Home); Therm-X (AT)Zenith Technical Innovations2024-06-21JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001096379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001096379008500010963798500010963790850001096379

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 Fahrenheit102 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062931546
Device count
1
Serial number
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446979128AIRCASTDJO, LLCJOW2026-08-03
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31