FDA.reportPublic FDA data

Performa

Primary DI
00885914070932
Brand
Performa
Company
Performance Health Supply, LLC
Model
081706738
Device description
Performa Adjustable Paraffin Bath
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00885914070932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885914070932008859140709328859140709320885914070932

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
966806150
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914040461Rolyan0813016392026-03-20
00885914040478Rolyan081301647N/A2026-03-20
00885914040485Rolyan081301654N/A2026-03-20
00885914004050METRON3030013030012016-09-16
00885914022023METRON9220999220992016-09-16
10885914075927METRON5687825687822017-01-31
10885914077440Performa0817107550817107552017-10-12
00885914077436Performa0817107480817107482017-10-13
00885914107898Sammons Preston70338453821302026-01-23
00885914107966Sammons Preston70338523821372026-01-23
00885914107973Sammons Preston70338533821382026-01-23
00885914107980Sammons Preston70338543821392026-01-23
00885914107997Sammons Preston70338553821402026-01-23
00885914108000Sammons Preston70338563821412026-01-23
00885914108017Sammons Preston70338573821422026-01-23
00885914108024Sammons Preston70338583821432026-01-23
00885914108031Sammons Preston70338593821442026-01-23
00885914108048Sammons Preston70338603821452026-01-23
00885914108055Sammons Preston70338613821462026-01-23
00885914108062Sammons Preston 70338623821472026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00645724004059Dickson Paraffin BathWhitehall Manufacturing CoIMC2018-11-12