FDA.reportPublic FDA data

MOBILE WHIRLPOOL (320L) - 220V

Primary DI
08436602170131
Brand
MOBILE WHIRLPOOL (320L) - 220V
Company
ORTOTECSA SL
Model
G.18951/E
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILJBath, Hydro-Massage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILJBath, Hydro-MassagePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436602170131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436602170131084366021701318436602170131

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
472631761
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436602170018MOBILE WHIRLPOOL (60L) - 220VG.18951/A2023-05-22
08436602170025MOBILE WHIRLPOOL (60L) - 120VG.18951/A (120V)2023-05-22
08436602170032MOBILE WHIRLPOOL ADJUSTABLE HEIGHT (60L) - 220VG.18951/A-12023-05-22
08436602170049MOBILE WHIRLPOOL ADJUSTABLE HEIGHT (60L) - 120VG.18951/A-1 (120V)2023-05-22
08436602170056MOBILE WHIRLPOOL (83L) - 220VG.18951/B2023-05-22
08436602170063MOBILE WHIRLPOOL (83L) - 120VG.18951/B (120V)2023-05-22
08436602170070MOBILE WHIRLPOOL ADJUSTABLE HEIGHT (83L) - 220VG.18951/B-12023-05-22
08436602170087MOBILE WHIRLPOOL ADJUSTABLE HEIGHT (83L) - 120VG.18951/B-1 (120V)2023-05-22
08436602170094MOBILE WHIRLPOOL (100L) - 220VG.18951/C2023-05-22
08436602170100MOBILE WHIRLPOOL (100L) - 120VG.18951/C (120V)2023-05-22
08436602170117MOBILE WHIRLPOOL (170L) - 220VG.18951/D2023-05-22
08436602170124MOBILE WHIRLPOOL (170L) - 120VG.18951/D (120V)2023-05-22
08436602170148MOBILE WHIRLPOOL (320L) - 120VG.18951/E (120V)2023-05-22
08436602170155HUBBARD TANK G.18957 2023-05-22
08436602170162HUBBARD TANK WITH SKIMMER G.18957-A 2023-05-22
08436602170179MOBILE WHIRLPOOL 230L (60 GAL) - 220VG.18951/2302023-05-22
08436602170186MOBILE WHIRLPOOL 230L (60 GAL) - 120VG.18951/230 (120V)2023-05-22
08436602170193MOBILE WHIRLPOOL 284L (75 GAL) - 220VG.18951/2902023-05-22
08436602170209MOBILE WHIRLPOOL 284L (75 GAL) - 120VG.18951/290 (120V)2023-05-22
08436602170216MOBILE WHIRLPOOL 340L (90 GAL) - 220VG.18951/3402023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874983844Apollo CorpAPOLLO CORP.ILJ2025-11-17
05059441219576Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219583Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219590Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219606Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219613Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219620Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219637Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219644Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219651Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219668Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219675Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219682Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219699Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219705Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268277Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268291Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268307Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306108Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306115Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306122Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310174Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310181Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310198Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310204Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310211Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310228Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310235Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310242Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310259Symbliss BathArjohuntleigh ABILJ2024-09-25