FDA.reportPublic FDA data

Dickson

Primary DI
00645724000006
Brand
Dickson
Company
Whitehall Manufacturing Co
Model
PB-104
Catalog number
PB-104
Device description
PARAFFIN BATH THERAPY 18 LBS. CAPACITY MOBILE PARAFFIN BATH
Published
2018-04-03
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

Contact Domains#

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
00645724000006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645724000006006457240000066457240000060645724000006

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 782-7706info@whitehallmfg.com

Regulatory Flags#

DUNS number
008312423
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
true
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
00645724004516Whitehall ThermalatorT12MLTEG26T12MLTEG262019-05-01
00645724004523ThermasplintSP1502EG26SP-1502-EG262019-05-01
00645724004530Whitehall ThermalatorsT4SEG26T-4-S-EG262019-05-01
00645724004547Hydrotherapy WhirlpoolE15MEG26E-15-M-EG262019-05-01
00645724000037Whitehall ThermalatorsET-12-M-FLATBTMET12MFLATBTM2019-02-11
00645724000044Whitehall ThermalatorsET-12-M-SPCORDET12MSPCORD2019-02-11
00645724000051Whitehall ThermalatorsET-4-S-SPCORDET4SSPCORD2019-02-11
00645724000068Whitehall ThermalatorsET-6-S-SPCORDET6SSPCORD2019-02-11
00645724000075Whitehall TheralatorsET-8-M-SPCORDET8MSPCORD2019-02-11
00645724003540ThermasplintSM-1501B-CORD2SM1501BCORD22019-02-11
00645724003557ThermasplintSM-1502B-CORD1SM1502BCORD12019-02-11
00645724003564ThermasplintSM-1502B-CORD2SM1502BCORD22019-02-11
00645724003571ThermasplintSM-1502B-CORD3SM1502BCORD32019-02-11
00645724003588ThermasplintSM-1502B-CORD4SM1502BCORD42019-02-11
00645724003595ThermasplintSM-1502B-CORD5SM1502BCORD52019-02-11
00645724003601ThermasplintSM-1502B-CORD7SM1502BCORD72019-02-11
00645724003618ThermasplintSP-1501B-CORD1SP1501BCORD12019-02-11
00645724003625ThermasplintSP-1501B-CORD2SP1501BCORD22019-02-11
00645724003632ThermasplintSP-1501B-CORD3SP1501BCORD32019-02-11
00645724003649ThermasplintSP-1501B-CORD4SP1501BCORD42019-02-11

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