FDA.reportPublic FDA data

PARATherm

Primary DI
00861047000329
Brand
PARATherm
Company
GRIMM SCIENTIFIC INDUSTRIES INC
Model
PARATherm
Device description
bath, paraffin
Published
2016-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMCBath, Paraffin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMCBath, ParaffinPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842423000PARA THERM BATHGrimm Scientific Industries, Inc.1984-06-28IMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861047000329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861047000329008610470003298610470003290861047000329

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

Contacts#

Phone, Email table
PhoneEmail
740.374.3412glenn@grimmscientific.com

Regulatory Flags#

DUNS number
107330599
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861047000312CRYOPressCRYOPress2016-08-14
00861047000305CRYOThermCRYOTherm2016-08-14

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