FDA.reportPublic FDA data

UFSK-OSYS Treatment chair

Primary DI
04057027552995
Brand
UFSK-OSYS Treatment chair
Company
UFSK-International OSYS GmbH
Model
500 XLS
Catalog number
15000005
Device description
Treatment chair for positioning and support of the patient for outpatient microsurgical treatments in ophthalmology, ENT and dental surgery
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMEChair, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMEChair, Ophthalmic, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057027552995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057027552995040570275529954057027552995

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
332808919
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
04057027018781UFSK-OSYS Surgeon's chairsurgiForce with comfort seat260000042026-03-02
04057027071816UFSK-OSYS Treatment chaireyeForce180000002026-03-02
04057027171257UFSK-OSYS Assistant's chairassistPro H240000092026-03-02
04057027212998UFSK-OSYS Surgeon's chairsurgiTrend with dynamic seat220000102026-03-02
04057027233726UFSK-OSYS Instrument tablesupportLine335100262026-03-02
04057027256831UFSK-OSYS Surgeon's chairsurgiForce light with formed seat260000092026-03-02
04057027338476UFSK-OSYS Treatment chair500 ECO150000082026-03-02
04057027349366UFSK-OSYS Assistant's chairassistPro F240000052026-03-02
04057027609606UFSK-OSYS Treatment chair500 XLE150000062026-03-02
04057027615751UFSK-OSYS Surgeon's chairsurgiForce with formed seat260000082026-03-02
04057027619605UFSK-OSYS Surgeon's chairsurgiLine with comfort seat220000132026-03-02
04057027637050UFSK-OSYS Surgeon's chairsurgiTrend with comfort seat220000122026-03-02
04057027659212UFSK-OSYS Surgeon's chairsurgiLine with formed seat220000082026-03-02
04057027753217UFSK-OSYS Assistant's chairassistTrend250000022026-03-02
04057027768129UFSK-OSYS Assistant's chaireasyLine F240000202026-03-02
04057027777473UFSK-OSYS Assistant's chaireasyLine R240000222026-03-02
04057027896099UFSK-OSYS Assistant's chairassistLine240000152026-03-02
04057027924617UFSK-OSYS Assistant's chaireasyPro F240000102026-03-02
04057027948156UFSK-OSYS Surgeon's chairsurgiForce light with comfort seat260000062026-03-02
04057027958162UFSK-OSYS Transport- and relaxing chairmotionLine170000002026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190022TOPCONANTONI CARLES SAHME2026-06-01
08436566190039TOPCONANTONI CARLES SAHME2026-06-01
08436566190046TOPCONANTONI CARLES SAHME2026-06-01
08436566190053TOPCONANTONI CARLES SAHME2026-06-01
00850003069753OC-2300TOPCON HEALTHCARE INCHME2026-05-06
00850003069760OC-2300TOPCON HEALTHCARE INCHME2026-05-06
00850003069739OC-2400TOPCON HEALTHCARE INCHME2026-03-13
04057027018781UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027071816UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027212998UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027256831UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027338476UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027609606UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027615751UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027619605UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027637050UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027659212UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027948156UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
00850003069630OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069647OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069654OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069661OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069678OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069685OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069692OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069708OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069715OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069722OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850053428746OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850053428753OC-2200TOPCON HEALTHCARE INCHME2025-10-31