FDA.reportPublic FDA data

Reliance

Primary DI
00850020301003
Brand
Reliance
Company
HAAG-STREIT USA, INC.
Model
FX520 Chair
Published
2020-09-09
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
00850020301003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020301003008500203010038500203010030850020301003

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic chair, line-poweredA mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080962286
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020301638RelianceElara Tabletop2026-05-29
00850020301607Reliance7800/ 7900 Refractor Arm-WC2025-08-04
00850020301614Reliance7800/ 7900 Refractor Arm-WC Value2025-08-04
00850020301621Reliance7800/ 7900 Third Arm2025-08-04
00850020301584Reliance7900V Floor Unit2025-05-21
00850020301539Reliance7900 Floor Unit2025-04-24
00850020301546RelianceBI Imaging2025-04-24
00850020301553RelianceBI-BM Rheostat2025-04-24
00850020301560RelianceBP-BQ Imaging2025-04-24
00850020301577RelianceBP-BQ Rheostat2025-04-24
00850020301591Reliance522V Chair2025-03-28
00850020301522Haag-Streit Surgical900 Surgical Chair2024-01-03
00850020301188RelianceEclipse2020-09-09
00850020301195Reliance7800/ 7900 Refractor Arm2020-09-09
00850020301201RelianceMonitor Arm2020-09-09
00850020301218RelianceWall Unit2020-09-09
00850020301225Reliance7900 Floor Unit2020-09-09
00850020301010Reliance7000 Chair2020-09-09
00850020301027Reliance710 Chair2020-09-09
00850020301034RelianceFXM920 Chair2020-09-09

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
04057027552995UFSK-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