FDA.reportPublic FDA data

TR1000 with straight armrests, US version

Primary DI
07350016061025
Brand
TR1000 with straight armrests, US version
Company
Tr Equipment AB
Model
0521000-US
Device description
TR1000 with straight armrests, US version
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350016061025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350016061025073500160610257350016061025

GMDN Terms#

Term, Definition table
TermDefinition
Bathing/changing table, mobileA raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354437485
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00735001606127TR3200-L Shower Trolley 2150*795cm, On board batteries, 4pcs castors with brake0532010-4B2023-12-11
07350016061261Hilo Bath TR 900 CWA US, Stainless Bathtub05192177-SS2023-12-11
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

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