FDA.report

Hydrotherapy Whirlpool

Primary DI
00645724002017
Brand
Hydrotherapy Whirlpool
Company
Whitehall Manufacturing Co
Model
DS-2516H
Catalog number
DS-2516H
Device description
MOBILE EXTREMITY WHIRLPOOL & U-CARRIAGE
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
00645724002017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645724002017006457240020176457240020170645724002017

GMDN Terms

TermDefinition
Hydrotherapy bath/tankA bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.

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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