FDA.reportPublic FDA data

TR900 HI LO 110V US

Primary DI
07350016061384
Brand
TR900 HI LO 110V US
Company
Tr Equipment AB
Model
05192153
Device description
TR900 HI LO 110V US
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KTCBath, Sitz, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTCBath, Sitz, NonpoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350016061384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350016061384073500160613847350016061384

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
354437485
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350016060035Ecoline with mixer, 50 MM DRAIN, H=80 CM051940322023-12-12
07350016060141TR1700 HI LO 230V incl. Mixer and shower051917012023-12-12
07350016060189TR900CW HI LO 230V Cleaning & Whirlpool051921702023-12-12
07350016060196TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool051921752023-12-12
07350016061414TR900C HI LO 230V Cleaning GE051921622023-12-12
07350016061421TR900C HI LO 110V Cleaning US051921632023-12-12
07350016061438TR900CW HI LO 230V Cleaning & Whirlpool UK TMV3051921712023-12-12
07350016061445TR900CW HI LO 110V Cleaning & Whirlpool US051921722023-12-12
07350016061452TR900CW HI LO 230V Cleaning & Whirlpool GE051921732023-12-12
07350016061469TR900A HI LO 230V Autofill 051921552023-12-12
07350016061476TR900A HI LO 230V Autofill GE051921562023-12-12
07350016061483TR900A HI LO 230V Autofill UK TMV3051921572023-12-12
07350016061490TR900CA HI LO 230V Cleaning & Autofill 051921652023-12-12
07350016061506TR900CA HI LO 230V Cleaning & Autofill GE051921662023-12-12
07350016061513TR900CA HI LO 110V Cleaning & Autofill US051921672023-12-12
07350016061520TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GE051921762023-12-12
07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool US051921772023-12-12
07350016061544TR900CW Fixed height 230V051922702023-12-12
07350016061551TR900CW Fixed height 110V US051922712023-12-12
07350016061568Hilo Bath TR 900 With Stainless Bathtub05192150-SS2023-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10661392012544LSL HEALTHCARELSL Industries, LLCKTC2025-05-16
07392532279409DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07392532279416DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07350016060035Ecoline with mixer, 50 MM DRAIN, H=80 CMTr Equipment ABKTC2023-12-12
07350016060141TR1700 HI LO 230V incl. Mixer and showerTr Equipment ABKTC2023-12-12
07350016060189TR900CW HI LO 230V Cleaning & WhirlpoolTr Equipment ABKTC2023-12-12
07350016060196TR900CWA HI LO 230V Cleaning, Autofill & WhirlpoolTr Equipment ABKTC2023-12-12
07350016061414TR900C HI LO 230V Cleaning GETr Equipment ABKTC2023-12-12
07350016061421TR900C HI LO 110V Cleaning USTr Equipment ABKTC2023-12-12
07350016061438TR900CW HI LO 230V Cleaning & Whirlpool UK TMV3Tr Equipment ABKTC2023-12-12
07350016061445TR900CW HI LO 110V Cleaning & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061452TR900CW HI LO 230V Cleaning & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061469TR900A HI LO 230V Autofill Tr Equipment ABKTC2023-12-12
07350016061476TR900A HI LO 230V Autofill GETr Equipment ABKTC2023-12-12
07350016061483TR900A HI LO 230V Autofill UK TMV3Tr Equipment ABKTC2023-12-12
07350016061490TR900CA HI LO 230V Cleaning & Autofill Tr Equipment ABKTC2023-12-12
07350016061506TR900CA HI LO 230V Cleaning & Autofill GETr Equipment ABKTC2023-12-12
07350016061513TR900CA HI LO 110V Cleaning & Autofill USTr Equipment ABKTC2023-12-12
07350016061520TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061544TR900CW Fixed height 230VTr Equipment ABKTC2023-12-12
07350016061551TR900CW Fixed height 110V USTr Equipment ABKTC2023-12-12
07350016061568Hilo Bath TR 900 With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061575Hilo Bath TR 900 TMV3, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061582Hilo Bath TR 900 US With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061599Hilo Bath TR 900 A, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061605Hilo Bath TR 900 A TMV3, Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061612COMFORTLINE II, BATHTUB,40 MM DRAIN, TMV3Tr Equipment ABKTC2023-12-12
07350016061629TR COMFORTLINE II, BATHTUB, 40 MM DRAIN, TMV2Tr Equipment ABKTC2023-12-12
07350016061636Comfortline HI LO 230V, 40mm drainTr Equipment ABKTC2023-12-12