FDA.reportPublic FDA data

Parabath

Primary DI
30087453240505
Brand
Parabath
Company
HYGENIC CORPORATION, THE
Model
24050
Catalog number
24050
Device description
Paraffin Heat Therapy Unit
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMCBath, Paraffin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMCBath, ParaffinPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30087453240505PackageGS12In Commercial Distribution
00087453240504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3008745324050530087453240505
00087453240504000874532405040874532405040087453240504

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy paraffin wax bathA mains electricity (AC-powered) tub/enclosure, with an internal heating assembly, intended to be filled with liquid paraffin wax for physical therapy. Symptomatic parts of the body (e.g., hands, fingers) are placed in the heated paraffin to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. Temperature settings and timing controls are typically included as part of the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004163390
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
false
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
00087453001662Hygenic155832026-01-13
00087453001679Hygenic155842026-01-13
00087453127560TheraBand Kinesiology Tape127562025-03-11
00087453127577TheraBand Kinesiology Tape127572025-03-11
00087453127584TheraBand Kinesiology Tape127582025-03-11
00087453143478Hysynal143472025-03-10
00087453127409TheraBand Kinesiology Tape127402025-03-10
00087453127447TheraBand Kinesiology Tape127442025-03-10
00087453127454TheraBand Kinesiology Tape127452025-03-10
00087453127461TheraBand Kinesiology Tape127462025-03-10
00087453127478TheraBand Kinesiology Tape127472025-03-10
00087453127492TheraBand Kinesiology Tape127492025-03-10
20087453143472Hysynal143472025-03-10
00087453127393TheraBand Kinesiology Tape127392025-03-10
00087453127416TheraBand Kinesiology Tape127412025-03-10
00087453102048Hysynal102042019-04-08
00087453127515TheraBand Kinesiology Tape 127512019-02-08
00087453127522TheraBand Kinesiology Tape 127522019-02-08
00087453127539TheraBand Kinesiology Tape 127532019-02-08
00087453127546TheraBand Kinesiology Tape 127542019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885914070932PerformaPerformance Health Supply, LLCIMC2025-03-26
00074108165213ConairCONAIR CORPORATIONIMC2023-07-07
00074108171023ConairCONAIR CORPORATIONIMC2023-07-07
00074108400703UP & UPTARGET CORPORATIONIMC2021-08-27
00702173122755TherabathWR MEDICAL ELECTRONICS CO INCIMC2020-03-11
00702173122809TherabathWR MEDICAL ELECTRONICS CO INCIMC2019-11-06
00074108381101CONAIR CORPORATIONCONAIR CORPORATIONIMC2019-05-03
00645724004080Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004097Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004103Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004110Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004127Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004134Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004141Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004158Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004165Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004172Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004189Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004196Dickson Paraffin BathWhitehall Manufacturing CoIMC2019-02-12
00645724004202Whitehall ThermalatorsWhitehall Manufacturing CoIMC2019-02-12
00645724004219Whitehall ThermalatorsWhitehall Manufacturing CoIMC2019-02-12
00645724004226ThermasplintWhitehall Manufacturing CoIMC2019-02-12
00645724004233Whitehall ThermalatorWhitehall Manufacturing CoIMC2019-02-12
00645724004240Whitehall ThermalatorsWhitehall Manufacturing CoIMC2019-02-12
00645724003953Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12
00645724004004Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12
00645724004011Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12
00645724004028Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12
00645724004035Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12
00645724004042Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12