FDA.report

Hydrotherapy Whirlpool

Primary DI
00645724002192
Brand
Hydrotherapy Whirlpool
Company
Whitehall Manufacturing Co
Model
E-15-S-0001
Catalog number
E-15-S-0001
Device description
STATIONARY EXTREMITY WHIRLPOOL
Published
2018-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ILJBath, Hydro-Massage

Product Code Classifications

CodeDeviceSpecialtyClass
ILJBath, Hydro-MassagePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00645724002192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645724002192006457240021926457240021920645724002192

GMDN Terms

TermDefinition
Hydro-massage turbineA mains electricity (AC-powered) device with a motor and impeller designed to be submerged in a water bathtub to aerate and circulate the water (whirlpool effect) for hydrotherapy, typically therapeutic massage for patients with musculoskeletal conditions.

Sterilization Methods

Method

Contacts

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 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

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05059441310242Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310259Symbliss BathArjohuntleigh ABILJ2024-09-25