FDA.reportPublic FDA data

Fresenius Medical Care

Primary DI
04052882002883
Brand
Fresenius Medical Care
Company
FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD
Model
T600B
Device description
Electric treatment chair for use in dialysis, day surgery and oncology applications designed to accommodate bariatric patients. The chair can be used for patients up to weight not exceeding 300kg ( 660 lb).
Published
2019-08-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
INOChair, Positioning, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INOChair, Positioning, ElectricPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091727000MEDICAL TREATMENT CHAIR, T400, T500,T600Fresenius Medical Care South Asia Pacific Pty , Ltd.2009-07-06INO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052882002883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052882002883040528820028834052882002883

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, electricA mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752905877
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052882003002Fresenius Medical Care T6882019-08-16
04052882003637Fresenius Medical Care T3882023-05-25
04052882002968Fresenius Medical Care T2002023-04-24
04052882003163Fresenius Medical CareT688B2022-06-23
04052882003651Fresenius Medical CareT5882022-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00606509500418MM5401Pride Mobility Products CorpINO2026-02-03
00606509500425MM5640Pride Mobility Products CorpINO2026-02-03
B247PL102Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PL103Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR104Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR401Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR446Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR454Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247PR455Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC105Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC464Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC465Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC476Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
B247UC480Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-12-08
00606509401685LC435PWPride Mobility Products CorpINO2025-11-14
00606509500401MM6420Pride Mobility Products CorpINO2025-09-05
B247PR519Chair, Electric PositioningGOLDEN BROTHERS, INC.INO2025-08-14
B247UC571Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-14
B247PR511Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR525Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR527Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
B247PR764Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-08-12
00606509500395MM8955Pride Mobility Products CorpINO2025-08-07
00606509500326MM3600Pride Mobility Products CorpINO2025-08-05
00606509500371MM8945Pride Mobility Products CorpINO2025-08-05
B47PR511Chair, Electric PosiitioningGOLDEN BROTHERS, INC.INO2025-06-18
00606509401661LC435XLPride Mobility Products CorpINO2024-12-19
00606509401678LC435XXLPride Mobility Products CorpINO2024-12-19
00606509401654PLR5900Pride Mobility Products CorpINO2024-10-31
00606509401579LC475SPride Mobility Products CorpINO2024-09-13