FDA.reportPublic FDA data

Thermotex

Primary DI
00183470000722
Brand
Thermotex
Company
Thermotex Therapy Systems Ltd.
Model
Neck
Published
2023-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00183470000722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00183470000722001834700007221834700007220183470000722

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203727354
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00183470000050ThermotexKnee2023-09-24
00183470000104ThermotexElbow2023-09-24
00183470000203ThermotexGold2023-09-24
00183470000258ThermotexPlatinum2023-09-24
00183470000302ThermotexProfessional2023-09-24
00183470000616ThermotexWrist Right2023-09-24
00183470000630ThermotexWrist Left2023-09-24
00183470000715InfraRXPlatinum2023-09-24
00183470000746InfraRXNeck2023-09-24
00183470000760InfraRXFoot2023-09-24
00183470000951ThermotexFoot2023-09-24

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