FDA.reportPublic FDA data

Leander

Primary DI
G509SERIES9000
Brand
Leander
Company
Leander, LLC
Model
L950
Device description
Examination/treatment motorized table with some articulated sections that can be adjusted into various accommodations for patient comfort and/or treatment. It is typically used by physical therapists and chiropractors.
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G509SERIES9000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117963502
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G509SERIES9500LeanderLT-9502024-02-19
G509SERIESSTAT0LeanderSTAT2024-02-19

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