FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G509SERIES9000PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
117963502
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G509SERIES9500LeanderLT-9502024-02-19
G509SERIESSTAT0LeanderSTAT2024-02-19

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20613647029293FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LGX2025-04-30
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